CN107205828A - variable angle plate - Google Patents

Abstract

A variable angle spinal plate assembly for securing and/or supporting a spine of a spinal column is provided. The variable angle bone plate includes a plurality of interleaved arcuate blades that facilitate relative movement between the first/second elements. An implant assembly is also provided that includes an angulating bone plate and associated first/second intervertebral plates extending therefrom. The varied angle bone plate generally includes a plurality of interleaved elements (e.g., upstanding tabs) that cooperate with opposing faces of the opening, which permits rotational movement between the first/second implant elements until a desired relative orientation is achieved. At this point, fixation/locking elements are typically employed to fix the first/second implant members relative to one another. The permitted rotational movement is generally based on the cooperative arcuate surfaces provided in the disclosed elements with freedom of movement in multiple planes, i.e., side-by-side and top-to-bottom.

Description

Translated fromChinese

变角度骨板variable angle plate

背景：background:

1.相关申请的交叉引用1. Cross-references to related applications

本申请要求于2014年11月24日提交的名称为“Angulating Bone Plate[变角度骨板]”并且被指定了序列号62/083,763的临时专利申请的优先权权益。以上临时专利申请的全部内容通过援引并入本文。This application claims the benefit of priority to Provisional Patent Application, entitled "Angulating Bone Plate," and assigned Serial No. 62/083,763, filed November 24, 2014. The entire contents of the above Provisional Patent Application are hereby incorporated by reference.

2.技术领域2. Technical field

本披露涉及用于固定和/或支撑骨的装置和系统。具体而言，本披露涉及一种用于固定和/或支撑脊柱的脊骨的脊柱板组件。本披露的板具有在外科手术的目的是为了融合一个或多个脊柱水平的情形下的具体应用。The present disclosure relates to devices and systems for immobilizing and/or supporting bone. In particular, the present disclosure relates to a spinal board assembly for immobilizing and/or supporting the spine of the spine. The plates of the present disclosure have particular application where the purpose of the surgery is to fuse one or more levels of the spine.

3.背景技术3. Background technology

脊柱板是常用的并且在现有技术中存在许多版本。现有技术脊柱板总体上由一个或多个结构元件构成，这些结构元件经由穿过这些结构元件中的孔洞并且进入这些椎体中的螺钉来连接至与有待融合的这一个或多个水平相邻的各椎体。通常提供某种类型的锁定机构来防止或阻挡螺钉经这些结构元件移回。可以用脊柱板来用于整个脊柱的融合。Spine boards are commonly used and there are many versions in the prior art. Prior Art Spinal Plates generally consist of one or more structural elements that are attached to the level or levels to be fused via screws that pass through holes in the structural elements and into the vertebral bodies. adjacent vertebral bodies. Some type of locking mechanism is usually provided to prevent or block the screw from moving back through these structural elements. A spinal board can be used for fusion of the entire spine.

在一些情形下，调整某个节段的脊柱前凸可能是有益的。实现该调整的一种方式是通过可调椎体间融合装置，例如Christensen的US 8,007,536所描述的。Christensen的‘536专利的内容通过援引并入本文。当调整该椎体间装置的脊柱前凸时，对脊柱板进行类似调整也可能是有益的。In some cases, it may be beneficial to adjust the lordosis of a certain segment. One way to achieve this adjustment is through an adjustable interbody fusion device, such as that described in US 8,007,536 to Christensen. The contents of Christensen's '536 patent are incorporated herein by reference. Similar adjustments to the spinal plate may also be beneficial when adjusting the lordosis of the interbody device.

本披露涉及容许一定范围的脊柱前凸并且接着可以锁定在选定的脊柱前凸位置中的脊柱板。The present disclosure relates to spinal boards that allow for a range of lordosis and can then lock into selected lordotic positions.

发明内容Contents of the invention

根据本披露，提供了一种有利的脊柱板。根据本披露的示例性脊柱板总体上包括两个彼此相关的结构元件。在组装好的位置中，这两个元件匹配形成板。在组合中，该板具有安装特征(例如，至少两个孔洞)以准许接骨螺钉或其他紧固件穿入这些结构元件并且接合椎体、例如与有待融合的椎间盘相邻的椎体。总体上，准许这两个元件相对于彼此移动，除非且直至接合了将这两个元件相对于彼此锁定的锁定特征。该锁定特征一般是可释放的，即，在希望时能够使得锁定功能“反转”。According to the present disclosure, an advantageous spinal board is provided. An exemplary spine board according to the present disclosure generally includes two structural elements that are related to each other. In the assembled position, the two elements mate to form a plate. In combination, the plate has mounting features (eg, at least two holes) to permit bone screws or other fasteners to penetrate the structural elements and engage a vertebral body, such as a vertebral body adjacent to a disc to be fused. Generally, the two elements are permitted to move relative to each other unless and until a locking feature locking the two elements relative to each other is engaged. The locking feature is generally releasable, ie the locking function can be "reversed" if desired.

本披露进一步提供了一种植入体组件，该植入体组件包括变角度骨板和从其延伸的相关联的第一/第二椎间板。该变角度骨板总体上包括多个交错元件(例如，直立接片)，这些交错元件与开口的对置面相协作，这准许第一/第二植入体元件之间的旋转移动，直至实现所希望的相对取向。此时，一般采用固定/锁定元件来将该第一/第二植入体元件相对于彼此固定。所准许的旋转移动一般是基于所披露元件中所提供的协作性弧形表面在多个平面中，即，并排和从上到下的移动自由度。The present disclosure further provides an implant assembly comprising a variable angle bone plate and associated first/second intervertebral plates extending therefrom. The variable angle bone plate generally includes a plurality of staggered elements (e.g., upstanding tabs) that cooperate with opposing faces of the opening, which permit rotational movement between the first/second implant elements until achieving The desired relative orientation. At this point, a fixation/locking element is generally employed to fix the first/second implant elements relative to each other. The rotational movement permitted is generally based on the degrees of freedom of movement in multiple planes, ie, side-by-side and top-to-bottom, provided by the cooperating arcuate surfaces provided in the disclosed elements.

与所披露的脊柱板相关联的额外的特征、功能和优点将从下面的详细说明中变得清楚，尤其是结合附图来阅读时。Additional features, functions and advantages associated with the disclosed spine board will become apparent from the following detailed description, especially when read in conjunction with the accompanying drawings.

附图说明Description of drawings

为了帮助本领域技术人员更好地理解如何制作和使用所披露的脊柱板，参考了附图，在附图中：To help those skilled in the art better understand how to make and use the disclosed spine board, reference is made to the accompanying drawings, in which:

图1是根据本披露的示例性脊柱板的斜视图；Figure 1 is an oblique view of an exemplary spine board according to the present disclosure;

图2是所披露脊柱板的示例性底部元件的斜视图；Figure 2 is an oblique view of an exemplary base member of the disclosed spine board;

图3是所披露脊柱板的示例性顶部元件的斜视图；Figure 3 is an oblique view of an exemplary top member of the disclosed spine board;

图4是根据本披露的示例性脊柱板的右截面视图；Figure 4 is a right cross-sectional view of an exemplary spine board according to the present disclosure;

图5是所披露脊柱板的示例性顶部元件的右截面视图；Figure 5 is a right cross-sectional view of an exemplary top member of the disclosed spine board;

图6是所披露脊柱板的示例性底部元件的右截面视图；Figure 6 is a right cross-sectional view of an exemplary bottom member of the disclosed spine board;

图7是所披露脊柱板的示例性底部元件的顶视图；Figure 7 is a top view of an exemplary bottom element of the disclosed spine board;

图8是所披露脊柱板的替代性示例性实施例的倾斜后视图；Figure 8 is an oblique rear view of an alternative exemplary embodiment of the disclosed spinal board;

图9是根据本披露的、呈组装好的构型的示例性骨板与椎体间装置的斜视图；9 is an oblique view of an exemplary bone plate and interbody device in an assembled configuration according to the present disclosure;

图10是图9所示的组装好的示例性骨板与椎体间装置的侧视图；Figure 10 is a side view of the assembled exemplary bone plate and interbody device shown in Figure 9;

图11是示例性植入体上部元件的斜视图，该植入体上部元件可以与植入体下部元件进行组装来限定根据本披露的骨板与椎体间装置；11 is an oblique view of an exemplary upper implant element that can be assembled with a lower implant element to define a bone plate and interbody device according to the present disclosure;

图12是图11所示的示例性植入体上部元件的顶视图；Figure 12 is a top view of the exemplary implant superior element shown in Figure 11;

图13是示例性植入体下部元件的斜视图，该植入体下部元件可以与植入体上部元件进行组装来限定根据本披露的骨板与椎体间装置；13 is an oblique view of an exemplary lower implant element that can be assembled with an upper implant element to define a bone plate and interbody device according to the present disclosure;

图14是图13所示的示例性植入体下部元件的侧视图；并且Figure 14 is a side view of the exemplary implant inferior element shown in Figure 13; and

图15是图8至图14的组装好的示例性骨板与椎体间装置的顶视图。15 is a top view of the assembled exemplary bone plate and interbody device of FIGS. 8-14.

具体实施方式detailed description

在本披露的示例性实施例中，提供了一种有利的脊柱板。初始地参照图1至图7，根据本披露的示例性脊柱板包括两个彼此相关的结构元件。在组装好的位置(图1)中，这两个元件(1，2)配合形成板。在组合中，该板具有至少两个孔洞(3)以准许接骨螺钉或其他紧固件穿入这些结构元件并且接合椎体，例如与有待融合的椎间盘相邻的椎体。总体上，准许这两个元件相对于彼此移动，除非并且直至将锁定特征接合，这会使得这两个元件相对于彼此锁定。该锁定特征一般是可拆卸或可逆的，从而使得可以允许这两个元件再次相对于彼此移动(如在临床应用中可能希望的)并且然后相对于彼此重新锁定(在多种场合)。In an exemplary embodiment of the present disclosure, an advantageous spinal board is provided. Referring initially to FIGS. 1-7 , an exemplary spine board according to the present disclosure includes two structural elements that are related to each other. In the assembled position (Fig. 1), the two elements (1, 2) cooperate to form a plate. In combination, the plate has at least two holes (3) to permit bone screws or other fasteners to pass through the structural elements and engage the vertebral bodies, for example adjacent to the intervertebral disc to be fused. Generally, the two elements are permitted to move relative to each other unless and until the locking feature is engaged, which locks the two elements relative to each other. The locking feature is generally detachable or reversible such that the two elements may be allowed to move relative to each other again (as may be desired in clinical applications) and then re-lock relative to each other (on various occasions).

为了描述的清晰起见，将这两个元件称为“顶部”和“底部”—这些指代是指这两个元件的基于患者的脊柱解剖学结构的相对定位，但是应当理解的是，“顶部”元件可以不背离本披露的精神或范围地是“底部”元件(并且反之亦然)。类似地，在不同的解剖学应用中，顶部/底部关系可以替代地是并排关系，如本领域技术人员应清楚的。For clarity of description, these two elements will be called "top" and "bottom"—these references refer to the relative positioning of these two elements based on the patient's spinal anatomy, but it should be understood that "top" A "element may be a "bottom" element (and vice versa) without departing from the spirit or scope of the present disclosure. Similarly, in different anatomical applications, the top/bottom relationship may alternatively be a side-by-side relationship, as will be apparent to those skilled in the art.

如图2和图3(分别示出了示例性底部和顶部元件)所示，这种配合是经由一系列相互作用的片状部(21，22，23，24，31，32，33)实现的，这些片状部从这些元件(25，35)的螺钉接纳部分朝向彼此延伸。底部元件的片状部(21，22，23，24)可以与顶部元件的片状部(31，32，33)之间所限定的间距或通道对齐，以实现该顶部元件相对于该底部元件的配合和滑动。每个片状部都限定了总体上平面的或弧形的几何形状，该几何形状进一步限定了两个总体上对置的面。当配合时，一个或多个“底部片状部”(例如，片状部22)被夹在两个“顶部片状部”(例如，片状部31、32)的对置面之间并且与它们处于面对关系。类似地，一个或多个“顶部片状部”(例如，片状部32)被定位在两个“底部片状部”(例如，片状部22、23)的对置面之间并且与它们处于面对关系。因此，元件1、2的配合总体上涉及与之相关联的协作片状部的交错。然而，应注意的是，单一片状部交错就可以有效地实现本披露的所希望临床结果，在这种情况下，单一片状部被定位在两个其他片状部的对置面之间并且与它们处于面对关系。As shown in Figures 2 and 3 (showing exemplary bottom and top elements respectively), this cooperation is achieved via a series of interacting flaps (21, 22, 23, 24, 31, 32, 33) Yes, the tabs extend towards each other from the screw receiving portions of the elements (25, 35). The flaps (21, 22, 23, 24) of the bottom element may be aligned with the spacing or channel defined between the flaps (31, 32, 33) of the top element to achieve fit and slide. Each flap defines a generally planar or arcuate geometric shape that further defines two generally opposed faces. When mated, one or more "bottom flaps" (eg, flaps 22) are sandwiched between opposing faces of two "top flaps" (eg, flaps 31, 32) and Be in a face-to-face relationship with them. Similarly, one or more "top flaps" (eg, flaps 32) are positioned between opposing faces of two "bottom flaps" (eg, flaps 22, 23) and They are in a face-to-face relationship. Thus, the cooperation of the elements 1 , 2 generally involves the interleaving of the cooperating flaps associated therewith. However, it should be noted that the desired clinical results of the present disclosure may be effectively achieved by interleaving a single sheet, in which case a single sheet is positioned between the opposing faces of two other sheets And be in a face-to-face relationship with them.

如图4至图6所示，优选的是，所有这些片状部(21，22，23，24，31，32，33)均具有如下的面，所述面是共享共用的中心的拱形(51，52，53，54，55，56，61，62，63，64，65，66)或者是由其(全部或部分)限定的。这种弧形几何形状确保了，一个元件(1)与另一个元件(2)的相对移动符合围绕该共用中心的旋转。第一元件相对于第二元件的这种“旋转”移动将与“平面平移”(即，并排的线性平移)形成对比，并且这样的“旋转”移动有利地促进了临床手术过程中的脊柱对齐。此后，一旦被锁定在位，所披露的骨板与植入体的组合就有效地建立了所希望的脊柱对齐。As shown in Figures 4 to 6, it is preferred that all of these lamellar portions (21, 22, 23, 24, 31, 32, 33) have faces that are arcuate sharing a common center (51, 52, 53, 54, 55, 56, 61, 62, 63, 64, 65, 66) or defined (in whole or in part) by it. This arcuate geometry ensures that the relative movement of one element (1) to the other (2) corresponds to a rotation about this common center. This "rotational" movement of the first element relative to the second element will be contrasted with "planar translation" (i.e., side-by-side linear translation), and such "rotational" movement advantageously facilitates spinal alignment during clinical procedures . Thereafter, once locked in place, the disclosed bone plate and implant combination effectively establishes the desired spinal alignment.

当所披露的板以如上文所描述的构型创建好、并且经由螺钉或其他紧固件施加到脊柱节段(即，椎体、椎间盘、椎体)的前面时，一个元件相对于另一个的移动将允许脊柱的屈曲/伸展移动，而不会显著地牵拉或压缩该脊柱节段。元件(1，2)的这种相对移动可以有益于实现进行融合手术的脊柱的恰当对齐，这已经显示是对结果有益的。When the disclosed plate was created in the configuration described above and applied to the front of the spinal segment (i.e., vertebral body, disc, vertebral body) via screws or other fasteners, the relative position of one element relative to the other Movement will allow flexion/extension movement of the spine without significantly stretching or compressing that spinal segment. This relative movement of the elements (1, 2) can be beneficial in achieving proper alignment of the spine undergoing fusion surgery, which has been shown to be beneficial to the outcome.

为了给经治疗的节段提供稳定性，这两个元件(1，2)必须相对于彼此锁定。在本披露的示例性实施例中，将这两个元件锁定在一起的装置是通过与这两个元件在结构上相关联的特征实现的。如图2所示，示例性的锁定特征包括紧固件(26)，该紧固件相对于底部元件(2)沿总体上从前到后的方向延伸。如图6所示，该紧固件连接至最后面的片状部(24)上或者是其的一体部分。更靠近前部的这些片状部中的每一者(21，22，23)都具有对齐的孔洞以准许该紧固件穿过。In order to provide stability to the treated segment, the two elements (1, 2) must be locked relative to each other. In an exemplary embodiment of the present disclosure, the means for locking the two elements together is achieved by a feature structurally associated with the two elements. As shown in Figure 2, an exemplary locking feature includes a fastener (26) extending in a generally front-to-rear direction relative to the bottom member (2). As shown in Figure 6, the fastener is attached to or is an integral part of the rearmost tab (24). Each of the tabs (21, 22, 23) closer to the front has holes aligned to allow the fastener to pass through.

在顶部元件(1)上，示例性片状部(31，32，33)各自具有槽缝36。该槽缝甚至在顶部元件(1)相对于底部元件(2)偏移时也使得紧固件(26)能够穿过该片状部。On the top element ( 1 ), the exemplary flaps ( 31 , 32 , 33 ) each have a slot 36 . The slot enables the fastener ( 26 ) to pass through the tab even when the top element ( 1 ) is offset relative to the bottom element ( 2 ).

为了将顶部元件(1)相对于底部元件(2)锁定，向该紧固件(26)的最前面(27)施加螺母(未示出)或功能性上类似的结构。在使用了螺母的实现方式中，紧固件(26)通常至少沿着其长度的最前面(27)是带螺纹的。根据本披露可以使用各种各样其他的紧固件，包括夹具、夹子、销钉、或类似的紧固结构。当拧紧该紧固件时，跨过每个片状部施加压缩力。通过使用结构材料(例如，不锈钢)或常用医疗植入体材料(例如，钛合金)，就在各片状部的每个面处产生显著的摩擦力。也可以使用结构塑料(例如，PEEK或UHMWPE)来(整体或部分地)制造该板，但是这些聚合物材料不太优选，因为当它们与它们自身相联接时会倾向于具有比常用于医疗植入体中的金属更低的摩擦系数。To lock the top element ( 1 ) relative to the bottom element ( 2 ), a nut (not shown) or functionally similar structure is applied to the frontmost ( 27 ) of this fastener ( 26 ). In implementations where nuts are used, the fastener (26) is generally threaded at least along the forwardmost (27) of its length. A variety of other fasteners may be used in accordance with the present disclosure, including clips, clips, pins, or similar fastening structures. When the fastener is tightened, a compressive force is applied across each flap. By using structural materials (eg stainless steel) or common medical implant materials (eg titanium alloys), significant friction is created at each face of the tabs. Structural plastics (eg, PEEK or UHMWPE) could also be used to make (in whole or in part) the plate, but these polymer materials are less preferred because they tend to have a higher density than those commonly used in medical implants when coupled to themselves. The metal in the body has a lower coefficient of friction.

通过具有片状部，这两个元件(1，2)锁定时维持其位置的摩擦力也成多倍，从而提供更大的稳定性。出于这个原因，对于给定尺寸的板，具有较大数量的片状部可以是有利的，但用较少的片状部也可实现有效的结果。实际上，可以存在少至一个从顶部元件延伸的片状部、以及至少两个从底部元件延伸的片状部(或反之亦然)，但是针对上文提及的稳定性/摩擦力属性，较大数量的交错式片状部可以是优选的(假设临床空间适应该板的尺寸)。By having a tab, the frictional force with which the two elements (1, 2) are locked to maintain their position is also multiplied, thus providing greater stability. For this reason, it may be advantageous to have a larger number of flakes for a given size of plate, but effective results can also be achieved with fewer flakes. In practice, there may be as few as one flap extending from the top element, and at least two flaps extending from the bottom element (or vice versa), but with respect to the stability/friction properties mentioned above, A larger number of interleaved flaps may be preferred (assuming the clinical space accommodates the size of the panel).

如上文所描述的，如图4至图6所示，这些片状部总体上在至少一个平面中是弯曲的。在垂直于拱形(51，52，53，54，55，56，61，62，63，64，65，66)的平面中，这些片状部可以是平坦或弯曲的。图7示出了在垂直平面中弯曲的片状部。这种构型的益处在于，它向这些独立片状部中的每一者赋予了较大的弯折刚度、并且还抵抗顶部元件相对于底部元件在与既定的所不同的方向上的平移和旋转。As described above, and as shown in FIGS. 4 to 6 , the flaps are generally curved in at least one plane. In a plane perpendicular to the arch (51, 52, 53, 54, 55, 56, 61, 62, 63, 64, 65, 66), these flaps may be flat or curved. Figure 7 shows a sheet bent in a vertical plane. The benefit of this configuration is that it imparts greater bending stiffness to each of the individual flaps and also resists translation and movement of the top element relative to the bottom element in directions other than intended. rotate.

当本披露的变角度骨板与椎间盘植入体(例如Christensen在US 8,007,536中描述的类型的椎间盘植入体)相联接时，就可以描述在术中调整节段脊柱前凸、并且然后将其固定在特定位置中的外科手术。When the variable angle bone plate of the present disclosure is coupled with an intervertebral disc implant, such as an intervertebral disc implant of the type described by Christensen in US 8,007,536, it can be described to adjust the segmental lordosis intraoperatively and then adjust it A surgical procedure that is fixed in a specific position.

该外科手术总体上执行如下：The surgical procedure is generally performed as follows:

1.以标准方式(例如，从前方、从侧方或从后方、以及在中间位置中，例如TLIF或经椎间孔)接近椎间盘空间。1. Approach the disc space in a standard manner (eg, from the front, from the side, or from the rear, as well as in medial locations, such as TLIF or transforaminal).

2.以该标准方式将椎间盘部分抽空。2. Partially evacuate the disc in this standard manner.

3.以该标准方式准备端板、取出软骨。3. Prepare the endplate and remove the cartilage in this standard manner.

4.将试验植入体放置在椎间盘空间中以确定适当大小的植入体。4. Place a trial implant in the disc space to determine the proper size implant.

5.将植入体(例如Christensen在US 8.007,536中描述的类型的植入体)植入该椎间盘空间中。5. Implantation of an implant, for example of the type described by Christensen in US 8.007,536, into the intervertebral disc space.

6.将根据本披露制造的板施加至与该植入体相邻。6. Apply a plate made according to the present disclosure adjacent to the implant.

7.将该脊柱节段定位以设定正确的脊柱前凸量。这可以用各种各样的手段(包括移动患者位于其上的手术台的一部分、或者在患者与床之间的某些位置处放置额外的垫子等)或者通过其他手段(例如，在外科手术之前在患者与床之间放置可充气气球、并且外科手术期间部分地充气以引起正确的脊柱前凸量)来完成。7. Position the spinal segment to set the correct amount of lordosis. This can be done by various means (including moving part of the operating table on which the patient is placed, or placing additional cushions at certain points between the patient and the bed, etc.) or by other means (e.g. This is done by previously placing an inflatable balloon between the patient and the bed, and partially inflating during surgery to induce the correct amount of lordosis).

8.一旦脊柱前凸令人满意，则使用紧固件/紧固机构来将本披露的板锁定在位。8. Once the lordosis is satisfactory, the fastener/fastening mechanism is used to lock the plate of the present disclosure in place.

应注意的是，如果希望，可以重复该定位/锁定步骤，即，通过首先释放紧固件/紧固机构、重设脊柱前凸的量、然后重新锁定所披露的板来固定调整后的脊柱前凸量。It should be noted that this positioning/locking step can be repeated if desired, i.e. immobilizing the adjusted spine by first releasing the fastener/fastening mechanism, resetting the amount of lordosis, and then relocking the disclosed plate The amount of lordosis.

替代地，本披露的板可以被制造成具有适合于接合植入体(例如Christensen在US8,007,536中披露的类型的植入体)的几何形状，使得该板和植入体可以进行预组装并且用单一步骤、而不是两个步骤(即上面的步骤5和6)来施加。Alternatively, the plates of the present disclosure may be fabricated with a geometry suitable for engaging an implant (such as an implant of the type disclosed by Christensen in US 8,007,536), so that the plate and implant may be pre-assembled and Apply in a single step rather than two steps (ie steps 5 and 6 above).

图8示出了本披露的替代性示例性实施例。在图8的替代性实施例中，该板被制造成具有适合于接合植入体的几何形状。具体地，图8示出了顶部元件(81)和底部元件(82)。示出了处于完全对齐/交错位置中的该顶部元件的片状部(83，84，85)和该底部元件的片状部(86，87，88，89)。朝向组装好的脊柱板的背部，可以存在利于与植入体接合的一个或多个特征。Figure 8 illustrates an alternative exemplary embodiment of the present disclosure. In the alternative embodiment of Figure 8, the plate is fabricated with a geometry suitable for engaging an implant. In particular, Figure 8 shows a top element (81) and a bottom element (82). The tabs (83, 84, 85) of the top element and the tabs (86, 87, 88, 89) of the bottom element are shown in a fully aligned/staggered position. Towards the back of the assembled spinal board, there may be one or more features that facilitate engagement with the implant.

如图8所示，该示例性实施例包括利于与植入体接合的表面和紧固件两者。例如，该顶部和底部元件的表面90和92分别可以有利地被成形为用于接合该植入体的前部。同样，取决于植入体的设计，可以提供一个或多个紧固件(91，93)来作为将所披露的板相对于植入体进行连接的装置。为此目的可以使用各种各样的紧固件，包括螺纹连接器、以及各种各样的夹具、夹子、销钉或类似的紧固结构。As shown in FIG. 8, this exemplary embodiment includes both surfaces and fasteners that facilitate engagement with the implant. For example, surfaces 90 and 92 of the top and bottom elements, respectively, may advantageously be shaped to engage the anterior portion of the implant. Also, depending on the design of the implant, one or more fasteners (91, 93) may be provided as a means of attaching the disclosed plate relative to the implant. A variety of fasteners may be used for this purpose, including threaded connectors, as well as various clips, clips, pins or similar fastening structures.

总体上优选的是，顶部元件(81)和底部元件(82)在该板的极端背部处均包括面，使得该顶部和底部元件均被适配成用于与植入体的不同部分相接合。这个设计特征能够实现组装好的板和植入体的插入、并且能够在原位调整旋转时同时操纵该板和植入体二者(例如，通过使到该顶部和底部元件相对于彼此伸出或叠缩)。It is generally preferred that both the top element (81) and the bottom element (82) comprise faces at the extreme back of the plate, so that both the top and bottom elements are adapted for engagement with different parts of the implant . This design feature enables the insertion of the assembled plate and implant and the simultaneous manipulation of both the plate and the implant while adjusting the rotation in situ (e.g., by protruding the top and bottom elements relative to each other or telescoping).

转到图9至图15，本文描绘且描述了本披露的另外一个示例性实现方式。具体而言，图9、10和15示出了示例性骨板与椎体间装置100，该装置包括植入体上部元件102(图11和12)和植入体下部元件104(图13和14)。该骨板与椎体间装置100-下文被称为“植入体组件100”-提供了第一/第二元件，这些元件一体地组合了与变角度骨板相关联的结构以及与椎体间装置或植入体相关联的结构。所披露的植入体组件100的椎体间装置/植入体方面可以有利地基于Christensen等人的美国专利号8,906,095的传授内容，该文献的内容通过援引以其全文并入文本。Turning to FIGS. 9-15 , another exemplary implementation of the present disclosure is depicted and described herein. Specifically, Figures 9, 10 and 15 show an exemplary bone plate and intervertebral body device 100 comprising an implant upper element 102 (Figures 11 and 12) and an implant lower element 104 (Figures 13 and 12). 14). The bone plate and interbody device 100 - hereinafter referred to as "implant assembly 100" - provides first/second elements that integrally combine the structures associated with the variable angle bone plate and the vertebral body. Inter-device or implant-associated structures. The interbody device/implant aspects of the disclosed implant assembly 100 may be advantageously based on the teachings of Christensen et al., US Patent No. 8,906,095, the contents of which are incorporated by reference in their entirety.

应注意，使用术语“下部”和“上部”是为了便于描述。然而，贯穿本披露应理解的是，“植入体下部元件”可以被定位在“植入体上部元件”的下部或上部，并且“植入体上部元件”可以被定位在“植入体下部元件”的下部或上部。因此，出于实施本披露的目的，术语“下部”和“上部”等效于“第一”和“第二”植入体元件，即，这些特征/功能可以根据本披露互换实施。It should be noted that the terms "lower" and "upper" are used for convenience of description. However, it should be understood throughout this disclosure that the "inferior implant element" may be positioned inferior or superior to the "superior implant element" and that the "superior implant element" may be positioned at the "inferior implant element". The lower or upper part of the element. Thus, for the purposes of practicing the present disclosure, the terms "inferior" and "superior" are equivalent to "first" and "second" implant elements, ie, these features/functions may be implemented interchangeably in accordance with the present disclosure.

如图9至图15所示，植入体上部元件102包括直立凸缘106，该直立凸缘限定了第一孔洞108和/或第二孔洞/开口110，该第一孔洞用于例如使用接骨螺钉或其他紧固件(未示出)来相对于椎体安装植入体上部元件102，并且该第二孔洞利于植入体上部元件102相对于植入体下部元件104的固定/锁定。孔洞/开口110的内部可以有利地是带螺纹的，以利于使用螺纹式螺钉/紧固件(未示出)实现所提及的固定/锁定功能。此外，孔洞/开口110的内部带螺纹准许将前行穿其而过的螺纹式螺钉/紧固件抽出，由此准许植入体上部元件102/植入体下部元件104“解锁”，如在临床上可能与植入体组件100的定位/植入相联系地希望的。As shown in FIGS. 9-15 , the implant superior element 102 includes an upstanding flange 106 defining a first hole 108 and/or a second hole/opening 110 for use, for example, with osteosynthesis. Screws or other fasteners (not shown) are used to mount the superior implant element 102 relative to the vertebral body, and the second hole facilitates fixation/locking of the superior implant element 102 relative to the inferior implant element 104. The interior of the hole/opening 110 may advantageously be threaded to facilitate the use of threaded screws/fasteners (not shown) for the mentioned securing/locking function. In addition, the internal threading of the holes/openings 110 permits the threaded screws/fasteners advanced therethrough to be withdrawn, thereby allowing the superior implant element 102/inferior implant element 104 to be "unlocked" as in It may be clinically desirable in connection with positioning/implantation of implant assembly 100 .

直立凸缘106总体上限定了弧形/半圆形顶面112和弧形/半圆形底面114。弧形/半圆形底面114总体上相对于直立凸缘106的侧面116、118向内呈台阶状，由此在弧形/半圆形底面114的任一侧上限定了第一和第二突沿面120、122。第一和第二突沿面120、122被适配成用于接合植入体下部元件104(参见图9)的对置区域，而弧形/半圆形底面114延伸进入由植入体内部元件104限定的对应的弧形/半圆形凹陷中并且与之相协作(如下文描述的)。第一椎间元件124从直立凸缘106延伸并且限定了第一和第二开口126、128。下文中将参照之前通过援引并入本文的美国专利号8,906,095更详细地描述第一椎间元件124的特征和功能。The upstanding flange 106 generally defines an arcuate/semi-circular top surface 112 and an arcuate/semi-circular bottom surface 114 . The arcuate/semi-circular bottom surface 114 is generally stepped inwardly relative to the sides 116, 118 of the upstanding flange 106, thereby defining first and second curved/semi-circular bottom surfaces 114 on either side thereof. Protruding edge surfaces 120,122. The first and second protrusion surfaces 120, 122 are adapted to engage opposing regions of the inferior implant element 104 (see FIG. 9 ), while the arcuate/semi-circular bottom surface 114 extends into the inner implant element. 104 defines a corresponding arcuate/semi-circular recess and cooperates therewith (as described below). A first intervertebral member 124 extends from the upstanding flange 106 and defines first and second openings 126 , 128 . The features and function of the first intervertebral member 124 are described in more detail below with reference to US Patent No. 8,906,095, previously incorporated herein by reference.

转向植入体下部元件104，应注意的是，这样的元件包括凸缘部分130，该凸缘部分限定了一对间隔开的孔洞/开口132、134以用于例如使用接骨螺钉或其他紧固件(未示出)来将植入体下部元件104相对于椎体固定。凸缘部分130还限定了弧形/半圆形凹陷136(在图13中最佳可见)，该凹陷被配置成用于接纳植入体上部元件102的弧形/半圆形底面114并且与之相协作。直立凸缘106和凸缘部分130的相互作用的弧形面准许植入体上部元件与植入体下部元件102、104之间的旋转运动。该旋转运动的程度受限于直立凸缘106所限定的第一和第二突沿面120、122与凸缘部分130的弧形/半圆形凹陷136的任一侧上所限定的对置的上面138、140的抵接相互作用。突沿面120、122和上面138、140的几何形状可以被形成为容许第一与第二植入体元件102、104之间的所希望水平的旋转自由度，如本领域技术人员基于本文的披露将清楚的。应注意的是，突沿面120、122和上面138、140可以通过伸展器械来用于引起节段的脊柱前凸。实际上，与这些表面/面中的一者或多者进行临床相互作用提供了引起脊柱前凸的替代性方法(参见上文概述的外科手术中的步骤7)。Turning to the lower implant element 104, it should be noted that such element includes a flange portion 130 that defines a pair of spaced apart holes/openings 132, 134 for fastening using, for example, bone screws or other A member (not shown) is used to fix the inferior implant element 104 relative to the vertebral body. The flange portion 130 also defines an arcuate/semicircular recess 136 (best seen in FIG. 13 ) configured to receive the arcuate/semicircular bottom surface 114 of the implant superior element 102 and in contact with phase cooperation. The interacting arcuate surfaces of the upstanding flange 106 and flange portion 130 permit rotational movement between the superior and inferior implant elements 102, 104. The degree of this rotational movement is limited by the first and second ledge surfaces 120 , 122 defined by the upstanding flange 106 and the opposing surfaces defined on either side of the arcuate/semi-circular recess 136 of the flange portion 130 . The abutment interaction of 138, 140 above. The geometry of the nosing surfaces 120, 122 and upper faces 138, 140 may be formed to allow a desired level of rotational freedom between the first and second implant elements 102, 104, as those skilled in the art based on the disclosure herein will be clear. It should be noted that the prosthetic surfaces 120, 122 and upper surfaces 138, 140 can be used to induce segmental lordosis by means of stretching instruments. Indeed, clinical interaction with one or more of these surfaces/faces provides an alternative method of inducing lordosis (see step 7 in the surgical procedure outlined above).

第二椎间元件142从凸缘部分130延伸并且限定了第一和第二开口144、146。下文中将参照之前通过援引并入本文的美国专利号8,906,095更详细地描述第二椎间元件142的特征和功能。The second intervertebral member 142 extends from the flange portion 130 and defines first and second openings 144 , 146 . The features and function of the second intervertebral member 142 are described in more detail below with reference to US Patent No. 8,906,095, previously incorporated herein by reference.

与第一椎间元件124和第二椎间元件142各自相关联的第一和第二开口涵盖了其对置面的表面积的显著部分、例如大于这样的表面积的50％。以此方式，利于骨长入植入体组件100中从而将第一和第二椎间元件124、142相对于彼此“固定”。然而，应理解的是，本披露不受其中的开口构成了所提及的程度的开口的这些实现方式限制或不限于这些实现方式。例如，该开口可以构成该表面积的较少百分比，例如在10％的等级上或者中间水平，例如在10％与50％之间。还进一步，这些开口可以构成该表面积的较大百分比，例如大于50％。另外应注意的是，在表面积中没有提供开口的示例性实施例中可以实现骨长入，例如其中通过骨至少部分地在第一和第二椎间元件前方进行生长而发生融合。The first and second openings associated with each of the first intervertebral element 124 and the second intervertebral element 142 encompass a substantial portion of the surface area of their opposing faces, for example greater than 50% of such surface area. In this manner, bone ingrowth into the implant assembly 100 is facilitated to "fix" the first and second intervertebral elements 124, 142 relative to each other. It should be understood, however, that the present disclosure is not limited or limited to such implementations in which the opening constitutes an opening of the degree mentioned. For example, the openings may constitute a small percentage of the surface area, eg on the order of 10%, or an intermediate level, eg between 10% and 50%. Still further, the openings may constitute a significant percentage of the surface area, for example greater than 50%. It should also be noted that bone ingrowth may be achieved in exemplary embodiments where no openings are provided in the surface area, eg, where fusion occurs by bone growing at least partially in front of the first and second intervertebral elements.

参照图11，植入体上部元件102限定了被界定的开口148，该被界定的开口嵌在第一椎间元件124的第一与第二开口126、128之间并且基本上在第一椎间元件124的中央轴线上居中。被界定的开口148的第一边界壁150限定了弧形表面、并且用作第一“片状部”以实现根据本披露的植入体上部元件102和植入体下部元件104的交错式相互作用的目的。对置的边界壁152可以由直立凸缘106的内面限定或者在其附近，并且这样的对置的边界壁152用作第二“片状部”，以实现根据本披露的植入体上部元件102和植入体下部元件104的交错式相互作用的目的。Referring to FIG. 11 , the implant superior element 102 defines a defined opening 148 that is embedded between the first and second openings 126, 128 of the first intervertebral element 124 and substantially at the first vertebral level. Centered on the central axis of the intermediate element 124. The first boundary wall 150 of the defined opening 148 defines an arcuate surface and acts as a first "flap" to achieve the staggered mutuality of the superior implant element 102 and the inferior implant element 104 according to the present disclosure. purpose of action. An opposed boundary wall 152 may be bounded by or adjacent the inner face of the upstanding flange 106, and such opposed boundary wall 152 acts as a second "flap" to achieve an implant superior element according to the present disclosure. 102 and the inferior implant element 104 for the purpose of staggered interaction.

转向图13和图14，植入体下部元件104限定了直立接片154，该直立接片被配置成且尺寸被确定成穿入植入体上部元件102的被界定的开口148中。直立接片154限定了弧形的相反面156、158，这些相反面与被界定的开口148的对应圆化边界壁150、152相协作，以准许植入体上部元件与植入体下部元件102、104之间的有限的轴向旋转移动。因此，直立接片154用作根据本披露的另外一个“片状部”，该直立接片154被配置成且尺寸被确定成插在植入体上部元件102所限定的对置片状部(即，其边界壁150、152)之间。Turning to FIGS. 13 and 14 , the inferior implant element 104 defines an upstanding tab 154 configured and dimensioned to pass into the defined opening 148 of the superior implant element 102 . The upstanding tab 154 defines arcuate opposite faces 156, 158 that cooperate with the corresponding rounded boundary walls 150, 152 of the defined opening 148 to allow the superior implant element to interact with the inferior implant element 102. , 104 limited axial rotational movement between. Thus, the upstanding tab 154 serves as another "flap" according to the present disclosure, configured and dimensioned to be inserted into the opposing tab defined by the superior implant element 102 ( That is, between its boundary walls 150, 152).

如图14所示，直立接片154限定了弧形表面156、158。与直立接片154和植入体上部元件102的对置边界壁150、152相关联的这种另外的圆化的几何形状准许植入体上部元件与植入体下部元件102、104之间的另外的旋转自由度。具体而言，基于交错的直立接片154和协作的边界壁150、152所容许的屈曲/伸展旋转移动自由度来重新定位上部和下部元件102、104是可能的。由此，也可以容许少量的侧向弯折旋转，即围绕前后轴线的旋转。As shown in FIG. 14 , the upstanding tabs 154 define arcuate surfaces 156 , 158 . This additional rounded geometry associated with the upstanding tab 154 and the opposing boundary walls 150, 152 of the superior implant element 102 permits contact between the superior implant element and the inferior implant element 102, 104. Additional rotational degrees of freedom. In particular, it is possible to reposition the upper and lower elements 102 , 104 based on the degrees of freedom of flexion/extension rotational movement allowed by the staggered upstanding tabs 154 and cooperating boundary walls 150 , 152 . Thereby, a small amount of lateral flex rotation, ie rotation about the front-to-back axis, may also be tolerated.

一旦临床上实现了植入体上部元件与植入体下部元件102、104的所希望的相对定位，则通过使锁定元件(未示出)行进穿过螺纹式孔洞/开口110以接合直立接片154的面158来使得植入体元件102、104相对于彼此固定/锁定。准许实现重新定位是通过使该锁定元件的方向反向来与面158解除接合、并且接着一旦实现所希望的相对取向就重新拧紧。Once the desired relative positioning of the implant superior and implant inferior elements 102, 104 is clinically achieved, the upstanding tabs are engaged by advancing a locking element (not shown) through the threaded hole/opening 110 154 to secure/lock the implant elements 102, 104 relative to each other. Repositioning is permitted by reversing the orientation of the locking element to disengage face 158 and then retightening once the desired relative orientation is achieved.

进一步参照图14，应注意的是，凸缘部分130相对于由第二椎间元件142限定的水平面限定了成角度的/弧形的向下延伸部。这种成角度的/弧形的几何形状有助于植入体下部装置104相对于周围解剖学结构的定位。With further reference to FIG. 14 , it should be noted that the flange portion 130 defines an angled/arcuate downward extension relative to the horizontal plane defined by the second intervertebral member 142 . This angled/arc geometry facilitates positioning of the inferior implant device 104 relative to the surrounding anatomy.

如在美国专利号8.906,095(通过援引并入本文)中更详细描述的，第一和第二椎间元件124、142的外部轮廓是相同的(或基本上相同的)，使得当联接/组装时，限定基本上均匀的外边缘/轮廓。因此，植入体组件100的第一和第二椎间元件的组合/组装轮廓限定了前边缘和后边缘。该前边缘可以分为以下三个(3)子区域以便描述：两个前外侧边缘环绕一个中央前边缘。与前外侧边缘相关联的、相对于该中央边缘下凹的几何形状可以允许将骨材料和/或其他希望的材料放在植入体组件100前方、在可以利于和/或引发骨融合的位置中。与这些前外侧边缘相邻的这个下凹区域还有利地容许放置/联接融合块体。第一和第二椎间元件124、142的外部轮廓还可以分为两个区域，其中板部分(106)不在中央、而是在前外侧，该前边缘的其余部分下凹。As described in more detail in U.S. Pat. No. 8.906,095 (incorporated herein by reference), the outer profiles of the first and second intervertebral elements 124, 142 are identical (or substantially identical) such that when coupled/ When assembled, a substantially uniform outer edge/profile is defined. Thus, the combination/assembly profile of the first and second intervertebral elements of implant assembly 100 defines an anterior edge and a posterior edge. The anterior edge can be divided into the following three (3) subregions for description: Two anterolateral edges surround a central anterior edge. The concave geometry associated with the anterolateral edge relative to the central edge can allow bone material and/or other desired materials to be placed in front of the implant assembly 100 in a position that can facilitate and/or induce bone fusion middle. This recessed area adjacent the anterolateral edges also advantageously allows placement/coupling of fusion blocks. The outer contours of the first and second intervertebral elements 124, 142 can also be divided into two regions, where the plate portion (106) is not central, but anterolateral, with the remainder of the anterior edge concave.

参照示例性植入体组件100的联接，应注意的是，第一和第二椎间元件124、142限定了协作性内面，这些协作性内面利于这两个元件之间在植入体组件100植入后持续初始时间段地发生相对移动。因此，第一椎间元件124的内面限定了一个中央区域和两个翼区域。该中央区域和一个翼区域一起形成或界定了开口126，而该中央区域和另一个翼区域形成或界定了开口128。With reference to the coupling of the exemplary implant assembly 100, it should be noted that the first and second intervertebral elements 124, 142 define cooperative inner surfaces that facilitate the connection between the two elements in the implant assembly 100. Relative movement occurs for an initial period of time after implantation. Thus, the inner face of the first intervertebral member 124 defines a central region and two wing regions. The central region and one wing region together form or define opening 126 , while the central region and the other wing region form or define opening 128 .

第二椎间元件142的内面也限定了一个中央区域和两个翼区域。该中央区域和第一翼区域一起形成或界定了开口144，而该中央区域和另一个翼区域形成或界定了开口146。The inner face of the second intervertebral member 142 also defines a central region and two wing regions. The central region and the first wing region together form or define an opening 144 , while the central region and the other wing region form or define an opening 146 .

植入体组件100的第一和第二椎间元件124、142有利地在使得第一椎间元件124的内面与第二椎间元件142的内面形成抵接接合时相对于彼此可移动地联接。当形成所提及的抵接接合时，第一椎间元件124的开口126基本上与第二椎间元件142的开口144对齐，并且第一椎间元件124的开口128基本上与第二椎间元件142的开口146对齐。还进一步，第一椎间元件124的中央区域与第二椎间元件142的中央区域呈抵接关系，以便在其间限定铰接区域(参见通过援引并入本文的美国专利号8,906,095中的图6)。The first and second intervertebral elements 124, 142 of the implant assembly 100 are advantageously movably coupled relative to each other when the inner surface of the first intervertebral element 124 is brought into abutting engagement with the inner surface of the second intervertebral element 142. . When the mentioned abutment engagement is formed, the opening 126 of the first intervertebral member 124 is substantially aligned with the opening 144 of the second intervertebral member 142 and the opening 128 of the first intervertebral member 124 is substantially aligned with the second intervertebral member. The opening 146 of the intermediate member 142 is aligned. Still further, a central region of the first intervertebral member 124 is in abutting relationship with a central region of the second intervertebral member 142 so as to define an articulation region therebetween (see FIG. 6 in U.S. Patent No. 8,906,095, incorporated herein by reference) .

总体上，该铰接区域提供了第一与第二椎间元件124、142之间的主要接触。在该第一椎间元件124的翼区域中形成的开口126、128和在该第二椎间元件142的翼区域中形成的开口144、146可以接纳骨材料(或其他材料)以利于骨长入其中。此外，该第一与第二椎间元件124、142的相应翼区域之间的相互作用/接触有利地起作用来限制其间的侧向弯折。在本披露的示例性实施例中，植入体组件100是关于前-后平面、即沿着该铰接区域所限定的平面对称(或基本上对称)的。Overall, the articulation region provides the primary contact between the first and second intervertebral members 124,142. The openings 126, 128 formed in the wing region of the first intervertebral member 124 and the openings 144, 146 formed in the wing region of the second intervertebral member 142 can receive bone material (or other material) to facilitate bone lengthening. into it. Furthermore, the interaction/contact between the respective wing regions of the first and second intervertebral elements 124, 142 advantageously acts to limit lateral bending therebetween. In an exemplary embodiment of the present disclosure, implant assembly 100 is symmetrical (or substantially symmetrical) about an anterior-posterior plane, ie, a plane defined along the articulation region.

第一椎间元件124的中央区域总体上被限定为扫掠表面，该扫掠表面沿中间-外侧方向具有第一轮廓并且沿前-后方向具有第二轮廓。总体上优选的是，沿中间-外侧方向的第一轮廓是单一拱形。总体上还优选的是，沿该前-后方向的轮廓是由线与拱形构成，其中该线与该拱形相切并且拱形在后。这种拱形组合有利地允许患者在屈曲-伸展时的正常解剖学运动、同时控制第一与第二椎间元件124、142之间的接触力。然而，本披露不受本文所描述的基于拱形的实现方式限制或者不限于该实现方式。The central region of the first intervertebral member 124 is generally defined as a swept surface having a first contour in the medial-lateral direction and a second contour in the anterior-posterior direction. It is generally preferred that the first profile in the medial-lateral direction is a single arch. It is also generally preferred that the profile in the anterior-posterior direction is formed by a line and an arch, wherein the line is tangent to the arch and the arch is behind. This arched combination advantageously allows normal anatomical movement of the patient in flexion-extension while controlling contact forces between the first and second intervertebral members 124,142. However, the present disclosure is not limited or limited to the arch-based implementations described herein.

第二椎间元件142的中央区域总体上也被限定为扫掠表面，该扫掠表面沿中间-外侧方向具有第一轮廓并且沿前-后方向具有第二轮廓。总体上优选的是，该第一轮廓是单一拱形。总体上还优选的是，该第二轮廓是由线构成。然而，正如第一椎间元件124，本披露不受本文所描述的基于拱形的实现方式限制或者不限于该实现方式。The central region of the second intervertebral member 142 is also generally defined as a swept surface having a first contour in the medial-lateral direction and a second contour in the anterior-posterior direction. It is generally preferred that the first profile is a single arch. It is also generally preferred that the second contour is formed from lines. However, as with the first intervertebral element 124, the present disclosure is not limited or limited to the arch-based implementation described herein.

为了减小接触应力，总体上优选的是，在该中间-外侧方向上这些配合的拱形的半径具有相似的(但不相同的)值，由此减小了该第一与第二椎间元件124、142之间的接触应力。并且，该第一椎间元件124的轮廓的范围一般大于该第二椎间元件142，以实现/利于第二椎间元件142相对于第一椎间元件124旋转。In order to reduce contact stress, it is generally preferred that the radii of the cooperating arches have similar (but not identical) values in the medial-lateral direction, thereby reducing the intervertebral space between the first and second vertebrae. Contact stress between elements 124,142. Also, the extent of the profile of the first intervertebral member 124 is generally larger than that of the second intervertebral member 142 to enable/facilitate rotation of the second intervertebral member 142 relative to the first intervertebral member 124 .

本披露的示例性第一与第二椎间元件124、142沿前-后方向的轮廓之间还存在有利的关系。例如，第一椎间元件124的前-后轮廓典型地与第二椎间元件142的前-后轮廓相匹配。前-后轮廓的这种匹配能够实现患者所必要的和/或希望的屈曲-伸展运动、并且利于所披露的椎间盘植入体在植入后初始时间段内的位置适应性。应注意的是，第一与第二椎间元件124、142的中央区域在对齐位置中限定了接触区域。还应注意的是，在中间-外侧轮廓与前-后轮廓之间，前-后曲线总体上不那么紧密地匹配。There is also a favorable relationship between the profiles of the exemplary first and second intervertebral elements 124, 142 of the present disclosure in the anterior-posterior direction. For example, the anterior-posterior profile of the first intervertebral element 124 typically matches the anterior-posterior profile of the second intervertebral element 142 . This matching of anterior-posterior contours enables necessary and/or desired flexion-extension motion of the patient and facilitates positional adaptability of the disclosed intervertebral disc implants for an initial period post-implantation. It should be noted that the central regions of the first and second intervertebral members 124, 142 define a contact region in the aligned position. It should also be noted that the anterior-posterior curves generally do not match so closely between the medial-lateral profile and the anterior-posterior profile.

虽然已经参照植入体组件100描述了示例性轮廓，但是还设想了各种各样的替代性轮廓。例如，可以由以下几何形状形成/限定中间-外侧轮廓，包括：圆化的对置面、椭圆形对置面、花键形对置面、或其他总体弯曲的元件。类似地，可以由以下几何形状形成/限定前-后侧轮廓，包括：圆化的对置面、椭圆形对置面、花键形对置面、或其他总体弯曲的元件。进一步设想的是，可以将铰接几何形状反向/颠倒，使得本文所描述的第一椎间元件124的所披露几何形状特征和功能可以替代地与第二椎间元件142相关联，并且反之亦然。因此，轮廓的几何特征/功能可以互换。然而，应注意的是，本文所描述的轮廓特征的反向可能不是优选的，因为第一和第二椎间元件124、142的旋转中心将潜在地偏移远离脊柱节段的自然旋转中心(被认为是在脊椎节段的下部分的后半部中)。并且，存在椎体间与板之间关系(对齐)的益处。即，限定该板的片状部的这些半径的中心应相对于这些前-后轮廓适当地定位。While exemplary profiles have been described with reference to implant assembly 100, a wide variety of alternative profiles are contemplated. For example, the medial-outer profile may be formed/defined by geometric shapes including: rounded opposing surfaces, elliptical opposing surfaces, splined opposing surfaces, or other generally curved elements. Similarly, the anterior-posterior profile may be formed/defined by geometric shapes including: rounded opposing surfaces, elliptical opposing surfaces, splined opposing surfaces, or other generally curved elements. It is further contemplated that the articulation geometry may be reversed/reversed such that the disclosed geometric features and functions of the first intervertebral member 124 described herein may be instead associated with the second intervertebral member 142, and vice versa. Of course. Thus, the geometric features/functions of the profiles are interchangeable. However, it should be noted that the inverse of the profile features described herein may not be preferred because the centers of rotation of the first and second intervertebral elements 124, 142 would potentially be offset away from the natural center of rotation of the spinal segment ( considered to be in the posterior half of the lower part of the vertebral segment). Also, there is a benefit of intervertebral to plate relationship (alignment). That is, the centers of the radii defining the flaps of the plate should be properly positioned relative to the anterior-posterior contours.

如本文所描述的，根据本披露的示例性椎间盘植入体组件被适配成用于临床插入椎体之间。该植入体总体上包括两个元件，这两个元件联接在一起而形成椎间盘植入体。这两个元件的对置表面被描述为内部联接表面、并且可以包括特征/协作性机构，这些特征/协作性机构有利地起作用来在所披露的脊柱植入体初始植入时将这些元件相对于彼此可移动地联接。因此，该联接装置/机构可以用来将第一和第二椎间元件相对于彼此连接和/或对齐。联接这些椎间元件可以调节该第一和第二椎间元件相对于彼此的移动，即在该第一和第二椎间元件基于骨长入而相对于彼此固定之前。因此，这两个椎间元件的联接并非将这些元件相对于彼此固定地定位。当这些元件根据本披露相联接时，总体上准许所述元件在至少一个方向上相对于彼此的微小移动。As described herein, an exemplary disc implant assembly according to the present disclosure is adapted for clinical insertion between vertebral bodies. The implant generally includes two elements that are coupled together to form the intervertebral disc implant. The opposing surfaces of the two elements are described as internal coupling surfaces and may include features/cooperative mechanisms that advantageously act to align these elements when the disclosed spinal implant is initially implanted. are movably coupled relative to each other. Thus, the coupling device/mechanism may be used to connect and/or align the first and second intervertebral elements relative to each other. Coupling the intervertebral elements may accommodate movement of the first and second intervertebral elements relative to each other, ie before the first and second intervertebral elements are fixed relative to each other based on bony ingrowth. Thus, the coupling of the two intervertebral elements does not fixedly position these elements relative to each other. When these elements are coupled in accordance with the present disclosure, slight movement of the elements relative to each other in at least one direction is generally permitted.

在本文所描述的第一与第二元件之间可以有利地定位第三元件。因此，例如，可以在该第一与第二元件之间定位非金属部件使之位于它们的接触区域之间。该非金属部件可以用聚合物材料(例如，聚乙烯、聚醚酮酮(PEKK)、和/或聚醚醚酮(PEEK))制成。该非金属部件可以采取片材、相对薄的块体或表面处理物的形式、并且有利地用于防止金属与金属的接触，由此降低金属失效的可能性。的确，所披露的聚合物材料的片材和/或块体在被原位引入该第一与第二元件之间时可以作为楔状结构来起作用。在示例性实施例中，所披露的聚合物材料可以被定位在和/或施加至所披露的椎间元件的第一和/或第二元件的一个或多个“凸形”部分上。A third element may advantageously be positioned between the first and second elements described herein. Thus, for example, non-metallic components may be positioned between their contact areas between the first and second elements. The non-metallic component may be made of a polymeric material (eg, polyethylene, polyetherketoneketone (PEKK), and/or polyetheretherketone (PEEK)). The non-metallic component may take the form of a sheet, a relatively thin block or a surface treatment, and advantageously serves to prevent metal-to-metal contact, thereby reducing the likelihood of metal failure. Indeed, the disclosed sheets and/or blocks of polymeric material may function as wedge-like structures when introduced in situ between the first and second elements. In exemplary embodiments, the disclosed polymeric material may be positioned on and/or applied to one or more "convex" portions of the first and/or second disclosed intervertebral elements.

如本文所描述的，所披露的脊柱植入体组件也可以受益于该第一和第二椎间元件相对于彼此的可移动性，该可移动性在临床上是基于所披露的椎间盘植入体的结构设计和操作而持续有限时间段地实现的。本披露的示例性椎间盘植入体组件包括：第一椎间元件，该第一椎间元件具有第一外部融合表面和第一内部联接表面；第二椎间元件，该第二椎间元件具有第二外部融合表面和第二内部联接表面；用于将该第一和第二椎间元件相对于彼此可移动地连接/联接的联接装置/机构。此外，每个椎间元件总体上包括实现/利于该第一和第二元件的进一步固定的一个或多个骨结合区段。As described herein, the disclosed spinal implant assembly may also benefit from the movability of the first and second intervertebral elements relative to each other clinically based on the disclosed intervertebral disc implant. The structural design and operation of the body are realized for a limited period of time. An exemplary intervertebral disc implant assembly of the present disclosure includes: a first intervertebral element having a first outer fusion surface and a first inner coupling surface; a second intervertebral element having a second outer fusion surface and a second inner coupling surface; a coupling means/mechanism for movably connecting/coupling the first and second intervertebral elements relative to each other. Furthermore, each intervertebral element generally includes one or more osseointegration segments that enable/facilitate further fixation of the first and second elements.

本文描述了关于与根据本披露设想的有利脊椎盘植入体组件相关联的形状、联接装置/机构、大小、材料、涂覆、涂覆材料、一个或多个骨结合区段/开口、切口/绕圆周内凹区域、暂时可移动性以及治疗方法的概览信息。Described herein are information regarding shapes, coupling means/mechanisms, sizes, materials, coatings, coating materials, osseointegration segments/openings, incisions associated with advantageous spinal disc implant assemblies contemplated in accordance with the present disclosure. /Overview information about the concave area around the circumference, temporary mobility and treatment methods.

a.形状a.shape

根据本发明的椎间盘植入体可以具有能够通过融合和骨长入来实现短期稳定并且刺激长期固定的任何形状。The intervertebral disc implant according to the present invention may have any shape that enables short-term stabilization through fusion and bony ingrowth and stimulates long-term fixation.

椎间盘植入体的形状(如从顶部看)可以包括例如修圆形、圆形、椭圆形、扁圆形或肾脏形状等几何形状。椎间盘植入体可以被设计成用于在后路或前路手术中使用、但是优选地被设计成在前路手术中使用，这可以使得手术后的恢复期较短。替代地，所披露的植入体可以被设计成用于经椎间孔腰椎体间融合术或外侧腰椎体间融合术。The shape of the intervertebral disc implant (as viewed from the top) may include geometric shapes such as rounded, circular, oval, oblate, or kidney-shaped. The disc implant may be designed for use in posterior or anterior procedures, but is preferably designed for use in anterior procedures, which may result in a shorter recovery period after surgery. Alternatively, the disclosed implants may be designed for transforaminal lumbar interbody fusion or lateral lumbar interbody fusion.

b.大小b. size

该椎间盘植入体的圆周可以小于椎体(corpus)的圆周。具体而言，所披露的椎间盘植入体的几何形状可以被限定成，使得椎体的基部相对于该植入体在其前部突出。例如，椎体可以相对于植入体突出至少0.2mm、并且可选地超过该植入体的边缘多达0.4mm或0.6mm。在本披露的另外的示例性实施例中，从植入体的外边缘到椎体的边缘的距离被限定为使得该距离在5mm或更大的量级上。The circumference of the disc implant may be smaller than the circumference of the corpus. In particular, the geometry of the disclosed intervertebral disc implant can be defined such that the base of the vertebral body protrudes anteriorly relative to the implant. For example, the vertebral body may protrude relative to the implant by at least 0.2mm, and optionally as much as 0.4mm or 0.6mm beyond the edge of the implant. In a further exemplary embodiment of the present disclosure, the distance from the outer edge of the implant to the edge of the vertebral body is defined such that the distance is on the order of 5mm or more.

这样的尺寸安排可以有利地提供和/或准许在椎间盘植入体的一侧处或沿该侧刺激骨生长、并且在将这些椎间元件相对于相邻的椎体固定之后，骨组织可以在所披露的椎间元件的外边缘处或沿着该外边缘连结，由此在植入后的一段时间后进一步将这些椎间元件相对于彼此固定。Such sizing can advantageously provide and/or allow bone growth to be stimulated at or along one side of the intervertebral disc implant, and after these intervertebral elements are fixed relative to the adjacent vertebral bodies, bone tissue can The disclosed intervertebral elements are joined at or along their outer edges, thereby further securing the intervertebral elements relative to each other after a period of time after implantation.

c.材料c.Material

根据本发明的椎间盘植入体组件可以由适合于植入的任意一种或多种材料制成。因此，所披露的植入体可以由选自但不限于下组中的一种或多种材料构造成：陶瓷、聚合物、骨和金属。优选的是金属、聚合物和陶瓷。该一种或多种材料在被加工成植入体之前和/或之后可以处于玻璃状、橡胶状、半结晶状或结晶状。Intervertebral disc implant assemblies according to the present invention may be made of any material or materials suitable for implantation. Accordingly, the disclosed implants may be constructed from one or more materials selected from, but not limited to, the group consisting of ceramics, polymers, bone, and metals. Preferred are metals, polymers and ceramics. The one or more materials may be glassy, rubbery, semicrystalline or crystalline before and/or after being processed into an implant.

在本披露的示例性实施例中，所披露的脊柱植入体可以由选自但不限于下组中的金属或金属合金构造成：不锈钢、钴-铬、钛(Ti)、钛合金、形状记忆合金(例如NiTi)、钽(Ta)、铌(Nb)、锆(Zr)、以及铂(Pt)。优选的金属和金属合金是钛、钽、钛合金、和钴铬、及其合金。根据本披露使用的示例性钴-铬材料包括CoCrMo合金。根据本披露使用的示例性钛合金包括Ti6Al4V。根据本披露使用的示例性不锈钢材料包括奥氏体不锈钢、特别是316和316L类型，以及不含Ni的不锈钢。In an exemplary embodiment of the present disclosure, the disclosed spinal implant may be constructed of a metal or metal alloy selected from, but not limited to, the following group: stainless steel, cobalt-chromium, titanium (Ti), titanium alloys, shaped Memory alloys such as NiTi, tantalum (Ta), niobium (Nb), zirconium (Zr), and platinum (Pt). Preferred metals and metal alloys are titanium, tantalum, titanium alloys, and cobalt chromium, and alloys thereof. Exemplary cobalt-chromium materials used in accordance with the present disclosure include CoCrMo alloys. Exemplary titanium alloys used in accordance with the present disclosure include Ti6Al4V. Exemplary stainless steel materials for use in accordance with the present disclosure include austenitic stainless steels, particularly types 316 and 316L, and Ni-free stainless steels.

可以使用诸如过渡金属的金属来制造根据本披露的椎间盘植入体。例如，可以采用钽(Ta)，一种耐腐蚀材料。实际上，钽对于根据本披露的植入体制造可以是有用的，因为它一般不受体液作用并且是无刺激性的。钛是耐腐蚀的第二过渡金属、提供高刚度、并且是生理学上惰性的，由此增强了其根据本披露的有用性。钛和钽具有不寻常的骨结合能力。此外，可以通过常规的成像方法来容易地分析由这些金属制造的椎间盘植入体的解剖学位置。Metals such as transition metals may be used to fabricate intervertebral disc implants according to the present disclosure. For example, tantalum (Ta), a corrosion-resistant material, may be used. Indeed, tantalum can be useful for implant fabrication according to the present disclosure because it is generally immune to humoral effects and is non-irritating. Titanium is a second transition metal that resists corrosion, provides high stiffness, and is physiologically inert, thereby enhancing its usefulness in accordance with the present disclosure. Titanium and tantalum have unusual osseointegration abilities. Furthermore, the anatomical position of intervertebral disc implants made of these metals can be easily analyzed by conventional imaging methods.

根据本披露使用的示例性陶瓷材料包括但不限于：生物惰性陶瓷(氧化铝(Al2O3)、部分稳定化的氧化锆(ZrO2)、氮化硅(Si3N4)、生物活性陶瓷(羟基磷灰石(Ca10(PO4)6(OH)2)和生物玻璃)、以及可再吸收陶瓷(例如，磷酸钙陶瓷，例如磷酸三钙Ca3(PO4)2)。磷灰石是指一组磷酸盐矿物，通常被称为羟基磷灰石、氟磷灰石和氯磷灰石，分别针对晶格中高浓度的OH--、F--或Cl--离子命名。羟基磷灰石是牙釉质的主要成分并且是骨材料的重要成分。羟基磷灰石是钙磷灰石的天然存在形式，其分子式为Ca5(PO4)3(OH)，但通常写成Ca10(PO4)6(OH)2，以表示晶体单位单元包括两个分子。羟基磷灰石容易被受体接受、并且提供对骨长入的显著刺激。Exemplary ceramic materials for use in accordance with the present disclosure include, but are not limited to: bioinert ceramics (alumina (Al2O3), partially stabilized zirconia (ZrO2), silicon nitride (Si3N4), bioactive ceramics (hydroxyapatite ( Ca10(PO4)6(OH)2) and bioglass), and resorbable ceramics (e.g., calcium phosphate ceramics such as tricalcium phosphate Ca3(PO4)2). Apatite refers to a group of phosphate minerals, usually Known as hydroxyapatite, fluoroapatite, and chloroapatite, named for the high concentration of OH--, F-- or Cl-- ions in the lattice, respectively. Hydroxyapatite is the main component of tooth enamel and Is an important component of bone material.Hydroxyapatite is a naturally occurring form of calcium apatite, its molecular formula is Ca5(PO4)3(OH), but it is usually written as Ca10(PO4)6(OH)2 to indicate the crystal unit The unit consists of two molecules. Hydroxyapatite is readily accepted by the receptors and provides significant stimulation of bone ingrowth.

大多数磷酸钙陶瓷是结晶物质。晶体经受高温下的热处理、并且烧结以产生生物陶瓷材料。在化学上它们是羟基磷灰石、磷酸三钙、或这两者的混合物。它们通常作为粉末、颗粒或多孔或无孔块体来提供。Most calcium phosphate ceramics are crystalline substances. The crystals are subjected to heat treatment at high temperature and sintered to produce a bioceramic material. Chemically they are hydroxyapatite, tricalcium phosphate, or a mixture of the two. They are usually supplied as powders, granules or porous or non-porous masses.

磷酸三钙比羟基磷灰石更多孔、并且生物降解速度快了十到二十倍。烧结温度也对成品的性能具有影响。根据制造条件，磷酸三钙将在几个月内被完全再吸收、或者花费几年来通过生物吸收被去除。在体内，它被部分地转化为羟基磷灰石，羟基磷灰石生物降解更慢。在本披露的示例性实施例中，采用了人造骨材料，例如可再吸收性陶瓷颗粒和可再吸收性磷酸三钙(TCP)陶瓷颗粒。Tricalcium phosphate is more porous than hydroxyapatite and biodegrades ten to twenty times faster. The sintering temperature also has an effect on the properties of the finished product. Depending on manufacturing conditions, tricalcium phosphate will be completely reabsorbed within a few months, or take years to be removed by bioabsorption. In the body, it is partially converted to hydroxyapatite, which biodegrades more slowly. In exemplary embodiments of the present disclosure, artificial bone materials such as resorbable ceramic particles and resorbable tricalcium phosphate (TCP) ceramic particles are employed.

所披露的脊柱植入体可以进一步完全或部分地使用对于刺激骨融合是高效的玻璃碳和热解碳来制做。The disclosed spinal implants can further be fabricated entirely or partially using glassy carbon and pyrolytic carbon that are highly effective at stimulating bone fusion.

用于完全或部分地制造根据本披露的脊柱植入体的示例性聚合物可以选自但不限于下组，该组为：聚交酯(PLA)、聚乙交酯(PGA)、聚酐、聚原酸酯、聚(D,L-乳酸)、聚(丙交酯-共-乙交酯)(PLGA)、聚-D,L-乳酸-聚(乙二醇)、聚磷酸酯、聚(甲基丙烯酸2-羟乙基酯)、聚(N-乙烯基吡咯烷酮)、聚(甲基丙烯酸甲酯)、聚(乙烯醇)、聚(丙烯酸)、聚丙烯酰胺、聚(乙烯-共-乙酸乙烯酯)、聚(甲基丙烯酸)、超高分子量聚乙烯(UHMWPE)、聚醚醚酮(PEEK)和聚醚酮酮(PEKK)。根据本披露的优选聚合物包括PEEK和PEKK。根据示例性实施例，根据本披露可以在对置的金属表面之间定位聚合物元件(例如，片材、块体、和/或表面处理物)。Exemplary polymers for the manufacture of spinal implants according to the present disclosure in whole or in part may be selected from, but are not limited to, the group consisting of polylactide (PLA), polyglycolide (PGA), polyanhydride , polyorthoester, poly(D,L-lactic acid), poly(lactide-co-glycolide) (PLGA), poly-D,L-lactic acid-poly(ethylene glycol), polyphosphate, Poly(2-hydroxyethyl methacrylate), poly(N-vinylpyrrolidone), poly(methyl methacrylate), poly(vinyl alcohol), poly(acrylic acid), polyacrylamide, poly(ethylene- co-vinyl acetate), poly(methacrylic acid), ultra-high molecular weight polyethylene (UHMWPE), polyether ether ketone (PEEK) and polyether ketone ketone (PEKK). Preferred polymers according to the present disclosure include PEEK and PEKK. According to exemplary embodiments, polymeric elements (eg, sheets, blocks, and/or surface treatments) may be positioned between opposing metal surfaces in accordance with the present disclosure.

完全或部分地用于制造根据本披露的脊柱植入体的示例性骨可以选自下组，该组为：异种移植物、同种异体移植物和自体移植物。根据本披露的优选骨包括异种移植物和同种异体移植物。Exemplary bones used in whole or in part to manufacture spinal implants according to the present disclosure may be selected from the group consisting of xenografts, allografts, and autografts. Preferred bones according to the present disclosure include xenografts and allografts.

所披露的植入体可以由一种或多种适合的材料制成。因此，在示例性实施例中，所披露的脊柱植入体由上述材料中的至少一种制成。在另外的实施例中，所披露的植入体由至少两种不同的材料制成。任一种材料可以构成例如整个植入体的1％与90％之间的总体积。因此，一种材料可以构成整个植入体的1％-10％、10％-20％、20％-30％、30％-40％、40％-50％、50％-60％、60％-70％、70％-80％或80％-90％的总体积。植入体的元件可以包括被可再吸收性陶瓷材料层包围的金属中央芯。在另外的实施例中，所披露的植入体由至少三种不同的材料制成。The disclosed implants can be made from one or more suitable materials. Accordingly, in an exemplary embodiment, the disclosed spinal implant is made of at least one of the materials described above. In additional embodiments, the disclosed implants are made of at least two different materials. Either material may constitute, for example, between 1% and 90% of the total volume of the entire implant. Thus, one material can constitute 1%-10%, 10%-20%, 20%-30%, 30%-40%, 40%-50%, 50%-60%, 60% of the entire implant - 70%, 70%-80% or 80%-90% of the total volume. Elements of the implant may comprise a metallic central core surrounded by a layer of resorbable ceramic material. In additional embodiments, the disclosed implants are made of at least three different materials.

椎间盘植入体的材料的弹性优选地具有与骨的弹性相似的量级。此外，可以用特定材料的涂层来覆盖一个或多个元件或元件的一部分以便优化功能。The elasticity of the material of the intervertebral disc implant is preferably of a similar order to that of bone. Furthermore, one or more elements or portions of elements may be covered with a coating of a particular material in order to optimize function.

d.涂覆d. Coating

可以进行植入体的涂覆以便在植入时并且在植入后的时期内保护植入体免受体液(包括血液)影响。可以替代地或另外使用涂层来通过将适合的化合物包括在内而控制植入体附近的骨生长。Coating of the implant may be performed to protect the implant from bodily fluids, including blood, at the time of implantation and for a period after implantation. Coatings may alternatively or additionally be used to control bone growth near the implant by including suitable compounds.

在示例性实施例中，所披露的植入体可以在这些元件的外部融合表面、内部联接表面、或开口的内表面上、或每个表面或任何表面组合的任何部分上被涂覆。在优选的实施例中，涂覆了这些开口的内表面。In exemplary embodiments, the disclosed implants may be coated on the outer fusion surface, the inner coupling surface, or the inner surface of the opening of these elements, or any portion of each surface or any combination of surfaces. In a preferred embodiment, the inner surfaces of these openings are coated.

该涂层总体上包括至少一个涂覆材料层。该涂覆材料可以选自任何适合的材料。因此，该涂层可以包括一种或多种骨诱导剂和/或成骨剂，如下文描述的。该涂层还可以采取适合的聚合物材料(例如，使得第一和第二椎间元件的金属与金属接触最小化的材料)的形式。该涂层可以进一步包括一种或多种抗生素。The coating generally includes at least one layer of coating material. The coating material can be selected from any suitable material. Accordingly, the coating may include one or more osteoinductive and/or osteogenic agents, as described below. The coating may also take the form of a suitable polymeric material (eg, a material that minimizes metal-to-metal contact of the first and second intervertebral elements). The coating may further include one or more antibiotics.

“被涂覆”是指涂覆材料可以仅位于被涂覆表面的外侧上。该涂层的厚度总体上是基于该涂层的所希望功能和特性来选择的、并且可以具有小于1mm、小于0.5mm、或小于0.25mm的厚度。该涂层的厚度也可以沿着所披露植入体的表面、例如在该植入体的不同表面点处发生改变。可以通过任何适合的涂覆方法、例如通过持续预定时间地将这些元件浸入涂覆材料的溶液中来执行对所披露的椎间盘植入体的涂覆。该涂覆材料还可以喷洒到植入体上；另一种可能性是通过刷涂来施加所述涂层。"Coated" means that the coating material may only be on the outside of the surface being coated. The thickness of the coating is generally selected based on the desired function and properties of the coating, and can have a thickness of less than 1 mm, less than 0.5 mm, or less than 0.25 mm. The thickness of the coating may also vary along the surface of the disclosed implants, for example at different surface points of the implant. Coating of the disclosed intervertebral disc implants may be performed by any suitable coating method, for example by immersing the elements in a solution of coating material for a predetermined period of time. The coating material can also be sprayed onto the implant; another possibility is to apply the coating by brushing.

e.涂覆材料e. Coating material

在本披露的示例性实施例中，可以在所披露的脊柱植入体上提供一个或多个保护性涂层，用于这样的保护性涂层的材料选自但不限于下组，该组为：聚乳酸(PLA)、聚乙交酯(PGA)、聚酐、聚原酸酯、聚(D,L-乳酸)、聚(丙交酯-共-乙交酯)(PLGA)、聚-D,L-乳酸-聚乙二醇、聚磷酸酯、与明胶海绵复合的聚(丙交酯-共-乙交酯)、聚(甲基丙烯酸2-羟乙基酯)、聚(N-乙烯基吡咯烷酮)、乙烯乙酸乙烯酯(EVA)、聚(甲基丙烯酸甲酯)、聚(乙烯醇)、聚(丙烯酸)、聚丙烯酰胺、聚(乙烯-共-乙酸乙烯酯)、聚(乙二醇)、聚(甲基丙烯酸)、L-PLA与聚己内酯的均聚物(PCL)、聚原酸酯、像聚(酐)和假聚(氨基酸)。所披露的聚合物材料可以有利地限制和/或消除根据本披露的第一与第二椎间元件之间的金属与金属的接触。In exemplary embodiments of the present disclosure, one or more protective coatings may be provided on the disclosed spinal implants, materials for such protective coatings being selected from, but not limited to, the group consisting of For: polylactic acid (PLA), polyglycolide (PGA), polyanhydrides, polyorthoesters, poly(D,L-lactic acid), poly(lactide-co-glycolide) (PLGA), poly -D,L-lactic acid-polyethylene glycol, polyphosphate, poly(lactide-co-glycolide) complexed with gelatin sponge, poly(2-hydroxyethyl methacrylate), poly(N -vinylpyrrolidone), ethylene vinyl acetate (EVA), poly(methyl methacrylate), poly(vinyl alcohol), poly(acrylic acid), polyacrylamide, poly(ethylene-co-vinyl acetate), poly (ethylene glycol), poly(methacrylic acid), homopolymer of L-PLA and polycaprolactone (PCL), polyorthoesters, like poly(anhydride) and pseudopoly(amino acid). The disclosed polymeric materials may advantageously limit and/or eliminate metal-to-metal contact between the first and second intervertebral elements according to the present disclosure.

在另外的示例性实施例中，该涂层可以含有生物活性成分，例如骨诱导剂和/或成骨剂(例如羟基磷灰石和/或磷酸三钙)或抗生素。作为实例，在涂层中包括骨诱导剂和/或成骨剂可以诱导早期成骨过程，例如特定细胞类型的趋化，而包括抗生素可以减少或防止微生物感染。In further exemplary embodiments, the coating may contain bioactive ingredients, such as osteoinductive and/or osteogenic agents (eg, hydroxyapatite and/or tricalcium phosphate) or antibiotics. As an example, including osteoinductive and/or osteogenic agents in the coating can induce early osteogenic processes, such as chemotaxis of specific cell types, while including antibiotics can reduce or prevent microbial infection.

也可以称为和/或包括“生长因子”的骨诱导剂和/或成骨剂总体上是与细胞表面上的受体结合的蛋白质，主要的结果是激活细胞迁移、细胞增殖和/或分化。许多骨诱导剂和/或成骨剂是非常多用的、刺激许多不同细胞类型的细胞划分，而其他专注于具体细胞类型。Osteoinductive and/or osteogenic agents, which may also be referred to and/or include "growth factors," are generally proteins that bind to receptors on the surface of cells with the primary result of activating cell migration, cell proliferation, and/or differentiation . Many osteoinductive and/or osteogenic agents are very versatile, stimulating cellular division of many different cell types, while others focus on specific cell types.

被认为是骨诱导性的材料一般含有形成素，例如骨形态发生蛋白。形成素通过刺激未分化细胞进行表型转化来引发组织和器官系统发育。根据本披露可以使用的合适的生长因子包括但不限于：组织生长增强物质(例如，生长和分化因子)，该物质包括血小板衍生生长因子(PDGF)、转化生长因子(TGF)、酸性和碱性成纤维细胞生长因子(FGF)、胰岛素样生长因子(IGF)、骨形态发生蛋白(BMP)及其组合。Materials considered to be osteoinductive generally contain morphogens, such as bone morphogenetic proteins. Formogens initiate tissue and organ system development by stimulating phenotypic transformation of undifferentiated cells. Suitable growth factors that may be used in accordance with the present disclosure include, but are not limited to: tissue growth enhancing substances (e.g., growth and differentiation factors) including platelet-derived growth factor (PDGF), transforming growth factor (TGF), acidic and basic Fibroblast growth factor (FGF), insulin-like growth factor (IGF), bone morphogenetic protein (BMP), and combinations thereof.

在本披露的示例性实施例中，骨诱导剂和/或成骨剂可以选自下组的骨生长因子中：血小板衍生生长因子(PDGF)(PDGF-AA、-AB、-BB)、胰岛素样生长因子I和II(IGF-I、IGF-II)、成纤维细胞生长因子(FGF)(酸性FGF-aFGF、碱性FGF-bFGF)、转化生长因子贝塔(TGF-B)(TGF-B(TGF-B 1，2，3，4和5))、骨诱导和骨形态发生蛋白(BMP)(BMP-1，BMP-2，BMP-3，BMP-4，BMP-5，BMP-6，BMP-7，BMP-8，BMP-9，BMP-10，BMP-11，BMP-12)、表皮生长因子(EGF)、牙骨质衍生的生长因子(CGF)、甲状旁腺激素相关蛋白(PTHrP)。优选的生长因子或骨诱导剂和/或成骨剂包括骨形态发生蛋白(BMP-1，BMP-2，BMP-3，BMP-4，BMP-5，BMP-6，BMP-7，BMP-8，BMP-9，BMP-10，BMP-11，BMP-12)和血小板衍生生长因子(PDGF)(PDGF-AA、-AB、-BB)。In an exemplary embodiment of the present disclosure, the osteoinductive and/or osteogenic agent may be selected from the group consisting of bone growth factors: platelet-derived growth factor (PDGF) (PDGF-AA, -AB, -BB), insulin Like growth factors I and II (IGF-I, IGF-II), fibroblast growth factor (FGF) (acidic FGF-aFGF, basic FGF-bFGF), transforming growth factor beta (TGF-B) (TGF-B (TGF-B 1, 2, 3, 4 and 5)), osteoinductive and bone morphogenetic proteins (BMP) (BMP-1, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 , BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12), epidermal growth factor (EGF), cementum-derived growth factor (CGF), parathyroid hormone-related protein (PTHrP). Preferred growth factors or osteoinductive and/or osteogenic agents include bone morphogenetic proteins (BMP-1, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP- 8, BMP-9, BMP-10, BMP-11, BMP-12) and platelet-derived growth factor (PDGF) (PDGF-AA, -AB, -BB).

根据本披露使用的涂层可以包括至少一种骨诱导剂和/或成骨剂、以及可选的多于一种这样的试剂，例如2种试剂、3种试剂、4种试剂、5种试剂、6种试剂、7种试剂、8种试剂、9种试剂、10种试剂或更多。本披露的示例性实现方式包括1、2、或3种骨诱导剂和/或成骨剂。更优选的实现方式包括1或2种骨诱导剂和/或成骨剂。Coatings used in accordance with the present disclosure may include at least one osteoinductive and/or osteogenic agent, and optionally more than one such agent, such as 2 agents, 3 agents, 4 agents, 5 agents , 6 reagents, 7 reagents, 8 reagents, 9 reagents, 10 reagents or more. Exemplary implementations of the present disclosure include 1, 2, or 3 osteoinductive and/or osteogenic agents. More preferred implementations include 1 or 2 osteoinductive and/or osteogenic agents.

可以将一层或多层的涂覆材料放在或施加到所披露的植入体上。在放置/施加了两个层或更多个层的实现方式中，这些层在组分上可以相同或不同，并且一个或多个层可以含有一种或多种骨诱导剂和/或成骨剂或其他生物活性成分。One or more layers of coating material may be placed or applied to the disclosed implants. In implementations where two or more layers are placed/applied, the layers may be the same or different in composition, and one or more layers may contain one or more osteoinductive and/or osteogenic agents or other biologically active ingredients.

替代地，骨诱导剂和/或成骨剂可以包括形成所披露的椎间盘植入体的元件的这些材料中的一种或多种。因此，植入体可以被设计成用于分泌这些骨诱导剂和/或成骨剂中的一种或多种，由此通过椎间盘植入体的元件来引导或以其他方式引发/支持对骨生长的刺激。所披露的椎间盘植入体优选地促进骨形成。Alternatively, osteoinductive and/or osteogenic agents may comprise one or more of these materials forming elements of the disclosed intervertebral disc implants. Accordingly, the implant can be designed to secrete one or more of these osteoinductive and/or osteogenic agents, thereby guiding or otherwise initiating/supporting bone formation by elements of the intervertebral disc implant. Growth stimulation. The disclosed disc implants preferably promote bone formation.

f.骨结合区段/开口f. Osseointegration section/opening

所披露的椎间盘植入体的第一和第二椎间元件通常包括和/或限定了骨结合区段。这样的区段总体上具有用于刺激和引导骨生长的能力。例如，这些椎间元件可以被适配成用于刺激骨生长以使每个这样的椎间元件的外表面相对于一个或多个相邻的椎骨元件融合。所披露的椎间元件总体上还被适配成用于进一步引导骨长入以便将这些椎间元件相对于彼此固定。The first and second intervertebral elements of the disclosed intervertebral disc implants generally include and/or define an osseointegration segment. Such segments generally have the ability to stimulate and guide bone growth. For example, the intervertebral elements may be adapted to stimulate bone growth to fuse the outer surface of each such intervertebral element relative to one or more adjacent vertebral elements. The disclosed intervertebral elements are also generally adapted for further guiding bony ingrowth so as to secure the intervertebral elements relative to each other.

该第一和第二椎间元件的内和外表面可以包括和/或限定根据本披露的被设计成用于优化骨长入的骨结合区段。如下文所描述的，骨结合区段可以完全或部分地由这些椎间元件的表面中的开口(例如，孔洞和/或切口)限定，这些开口提供了骨长入的进入点。这些骨结合区段还可以包括适合的骨诱导剂和/或成骨剂、和/或骨诱导材料和/或成骨材料。本披露的实现方式(其中在椎间元件中形成的开口包括骨诱导剂和/或成骨剂，和/或在此类开口内的骨诱导材料和/或成骨材料)被称为“经填充的”开口。The inner and outer surfaces of the first and second intervertebral elements may include and/or define osseointegration segments designed to optimize bone ingrowth according to the present disclosure. As described below, the osseointegration zone may be fully or partially defined by openings (eg, holes and/or incisions) in the surfaces of the interspinous elements that provide entry points for bony ingrowth. These osseointegrating segments may also comprise suitable osteoinductive and/or osteogenic agents, and/or osteoinductive and/or osteogenic materials. Implementations of the present disclosure in which openings formed in intervertebral elements include osteoinductive and/or osteogenic agents, and/or osteoinductive and/or osteogenic materials within such openings are referred to as " filled" opening.

在本披露的示例性实施例中，所披露的椎间元件包括或限定了适于骨长入的一个或多个开口，这样的开口大到足以(i)允许成骨细胞和骨原细胞进入、并且(ii)维持此类成骨细胞和骨原细胞的成活力。这些开口典型地前进或延伸穿过所披露的椎间元件、允且许骨长入穿过这些元件。这些开口可以具有与椎间盘植入体的椎间元件的设计/几何形状相兼容的任何形状或大小。例如，这些开口可以构成或限定延伸穿过该椎间元件的笔直(或基本上笔直)通道。在示例性实施例中，该一个或多个开口的直径可以随着通道延伸穿过这些椎间元件而变化，例如，开口通道的直径可以藉由元件中的内部空隙而扩大。In an exemplary embodiment of the present disclosure, the disclosed intervertebral element includes or defines one or more openings suitable for bone ingrowth, such openings being large enough to (i) allow entry of osteoblasts and osteoprogenitors , and (ii) maintaining the viability of such osteoblasts and osteoprogenitors. These openings typically advance or extend through the disclosed intervertebral elements, allowing and allowing bone ingrowth through the elements. These openings may be of any shape or size compatible with the design/geometry of the intervertebral elements of the disc implant. For example, the openings may constitute or define straight (or substantially straight) passages extending through the intervertebral element. In an exemplary embodiment, the diameter of the one or more openings can vary as the channels extend through the intervertebral elements, for example, the diameter of the open channels can be enlarged by internal voids in the elements.

这些椎间元件的、被这些开口占据的表面积总体上足够支撑所希望水平的骨长入，以便随时间流逝实现第一和第二椎间元件相对于彼此的固定。然而，应注意的是，此类骨长入总体上不限于骨穿过此类开口生长、而是补充有沿着或围绕这些椎间元件的外边缘延伸的骨长入。在本披露的示例性实施例中，这些开口占据第一和/或第二椎间元件的表面积的至少5％，并且在另外的示例性实施例中此类表面的至少10％或至少15％是为了准许/刺激骨的充分长入。在另外的示例性实施例中，第一和/或第二个椎间元件的、被这些开口/孔洞占据的表面积是此类表面积的10％-40％、例如其20％-35％。这些开口和内部空隙体积可以构成所披露的椎间盘植入体的椎间元件的总体积的10％-90％，例如这些椎间元件的总体积的20％-80％、30％-70％、40％-60％和/或30％-60％。The surface area of the intervertebral elements occupied by the openings is generally sufficient to support a desired level of bony ingrowth to achieve fixation of the first and second intervertebral elements relative to each other over time. It should be noted, however, that such ingrowth is generally not limited to bone growth through such openings, but is supplemented by bone ingrowth extending along or around the outer edges of the intervertebral elements. In exemplary embodiments of the present disclosure, these openings occupy at least 5% of the surface area of the first and/or second intervertebral element, and in further exemplary embodiments at least 10% or at least 15% of such surfaces This is to allow/stimulate adequate ingrowth of the bone. In further exemplary embodiments, the surface area of the first and/or second intervertebral element occupied by these openings/holes is 10%-40%, such as 20%-35% of such surface area. These openings and internal void volumes may constitute 10%-90% of the total volume of the intervertebral elements of the disclosed intervertebral disc implants, such as 20%-80%, 30%-70%, 40%-60% and/or 30%-60%.

当提及椎间元件的总体积时，不包括联接区域的体积，而仅包括这些独立椎间元件的大致体积(包括开口的体积和内部空隙体积(如果存在的话))。When referring to the total volume of an intervertebral element, the volume of the articulation region is not included, but only the approximate volume of these individual intervertebral elements (including the volume of the opening and the volume of the internal void, if present).

在本披露的示例性实施例中，当椎间元件经由联接装置/机构彼此接合时，该第一和第二椎间元件的该一个或多个开口彼此相对，即基本上对齐。此类开口的对置/对齐安排提供了促进骨穿过这两个椎间元件长入以实现本披露的以下希望目的的最佳条件：这些目的例如是，当在由这些椎间元件的内表面所形成/限定的联接区域中形成了骨组织时，椎间盘植入体在每个外表面处相对于相邻椎体融合以及这些椎间盘植入体元件的第一和第二椎间元件相对于彼此固定。In an exemplary embodiment of the present disclosure, the one or more openings of the first and second intervertebral elements oppose each other, ie are substantially aligned, when the intervertebral elements are engaged with each other via the coupling device/mechanism. The opposed/aligned arrangement of such openings provides optimal conditions for promoting bone ingrowth through the two intervertebral elements to achieve the following desired purposes of the present disclosure: When bone tissue is formed in the coupling area formed/limited by the surfaces, the intervertebral disc implant fuses with respect to the adjacent vertebral body at each outer surface and the first and second intervertebral elements of these intervertebral disc implant elements relative to fixed to each other.

一个或这两个椎间元件的表面上的较小开口可以被表示为“孔隙”，这些孔隙影响植入体刺激这些表面处的骨生长的能力。植入体的孔隙度、孔径分布、孔隙形态以及孔隙互连程度显著地影响骨生长的程度。用于促进骨诱导的、该第一和/或第二椎间体的外表面上的示例性孔体积为150-500mm3。此外，一个或这两个椎间元件的外表面进一步可以是粗糙的、不平的或颗粒状的，以进一步促进相对于相邻椎体的融合。Smaller openings on the surfaces of one or both intervertebral elements may be represented as "pores" which affect the ability of the implant to stimulate bone growth at these surfaces. Implant porosity, pore size distribution, pore morphology, and degree of pore interconnection significantly affect the extent of bone growth. An exemplary pore volume on the outer surface of the first and/or second intervertebral body for promoting osteoinduction is 150-500 mm3. Additionally, the outer surface of one or both intervertebral elements may further be roughened, uneven, or grained to further facilitate fusion relative to adjacent vertebral bodies.

g.切口/绕圆周内凹区域g. Incision / concave area around the circumference

替代如上文所描述的开口或与之相组合，所披露的一个或多个椎间元件可以包括或限定多种不同形状/几何形状的切口或绕圆周凹入区域，以利于骨长入以及第一和第二椎间元件随时间流逝的固定。因此，在本披露的示例性实施例中，在这些椎间元件中并且穿过其的开口可以与切口/绕圆周内凹区域相组合以提高/利于所希望的骨长入水平。例如，所披露的开口和切口/绕圆周内凹区域可以通过提供支架来供细胞移动入并产生新骨来刺激骨传导作用。Instead of or in combination with openings as described above, one or more of the disclosed intervertebral elements may include or define a variety of different shapes/geometry cutouts or recessed areas around the circumference to facilitate bone ingrowth and Fixation of the first and second intervertebral elements over time. Thus, in exemplary embodiments of the present disclosure, openings in and through these intervertebral elements may be combined with cutouts/circumferential recessed regions to enhance/facilitate a desired level of bone ingrowth. For example, the disclosed openings and cutouts/circumferentially recessed areas can stimulate osteoconduction by providing a scaffold for cells to move into and create new bone.

如上文描述的，所披露的椎间盘植入体的椎间元件可以由一种或多种不同的材料制成。在本披露的示例性实施例中，可以将填充物定位在椎间盘植入体的椎间元件的开口和/或切口/绕圆周内凹区域中，由此获得经填充的植入体。填充物可以包括适合用于引导和/或刺激成骨活动和或抑制骨再吸收作用的一种或多种材料。例如，可以用骨或脱钙骨基质(DBM)的自体移植物和/或同种异体移植物来作为填充材料。还可以采用人造骨材料，例如陶瓷材料。还可以利用可再吸收材料，例如可再吸收陶瓷颗粒，从而允许和/或利于骨在这些开口和/或切口/绕圆周内凹区域中在适合的时间内形成。因此，所披露的脊柱植入体可以填充有可再吸收材料(例如可再吸收陶瓷颗粒)，这些材料通过适当的装填而可以有助于骨长入的时间和/或程度。在另外的示例性实施例中，填充物可以包括如关于涂层所描述的骨诱导剂和/或成骨剂。As described above, the intervertebral elements of the disclosed intervertebral disc implants can be made from one or more different materials. In an exemplary embodiment of the present disclosure, a filler may be positioned in the opening and/or incision/circumferentially concave region of the intervertebral element of the intervertebral disc implant, thereby obtaining a filled implant. The filler may comprise one or more materials suitable for directing and/or stimulating osteogenic activity and or inhibiting bone resorption. For example, autografts and/or allografts of bone or demineralized bone matrix (DBM) can be used as filling material. Artificial bone materials, such as ceramic materials, may also be used. Resorbable materials may also be utilized, such as resorbable ceramic particles, to allow and/or facilitate bone formation in these openings and/or incisions/circumferentially recessed areas within a suitable time. Accordingly, the disclosed spinal implants can be filled with resorbable materials (eg, resorbable ceramic particles) that, with proper packing, can aid in the timing and/or extent of bone ingrowth. In further exemplary embodiments, the filler may include osteoinductive and/or osteogenic agents as described for the coating.

h.植入体的融合h. Implant fusion

根据本披露的脊椎盘植入体有利地与周围的椎骨融合。具体而言，该第一和第二椎间元件的外部融合表面适合于与邻近的骨/椎体融合。所披露的椎间盘植入体的元件被构造成用于刺激骨传导作用，即引导骨穿过该植入体的椎间元件生长。这种骨长入导致该第一和第二椎间元件相对于彼此的固定。在本披露的多个示例性实施例中，第一和第二椎间元件相对于彼此的固定(导致固定植入体的形成)至少部分地是由骨长入造成的，该骨长入主要穿过椎间盘植入体的椎间元件的这一个或多个骨结合区段发生。Spinal disc implants according to the present disclosure advantageously fuse with the surrounding vertebrae. In particular, the outer fusion surfaces of the first and second intervertebral elements are adapted to fuse with adjacent bone/vertebral bodies. The disclosed elements of the intervertebral disc implant are configured to stimulate osteoconduction, ie, guide bone growth through the intervertebral elements of the implant. This bony ingrowth results in fixation of the first and second intervertebral elements relative to each other. In various exemplary embodiments of the present disclosure, the fixation of the first and second intervertebral elements relative to each other (resulting in the formation of the fixation implant) is caused at least in part by bony ingrowth, which primarily The one or more segments of osseointegration of the intervertebral element through the intervertebral disc implant occurs.

i.治疗方法i. Treatment

患有由于脊椎损伤或其他疾病造成的腰痛和/或腿部疼痛的个体可能通过插入椎间盘植入体而获得缓解。本披露的一方面涉及一种或多种治疗有需要的个体的方法，其中该方法包括插入椎间盘植入体。所披露的方法可以通过前路、外侧、后路、和或经椎间孔插入来实现。此外，所披露的方法可以与插入/植入(或预先存在的)后路稳定器件/装置相组合。后路稳定可以处于以下形式：柔性(动态)、半刚性或刚性植入体，例如椎弓根螺钉，棘突间撑开器或小关节螺钉或本领域已知或随后开发的任何其他固定/稳定方法。Individuals with low back pain and/or leg pain due to spinal injuries or other conditions may find relief through the insertion of a disc implant. An aspect of the present disclosure relates to one or more methods of treating an individual in need thereof, wherein the method comprises inserting a disc implant. The disclosed methods can be accomplished through anterior, lateral, posterior, and or transforaminal insertions. Additionally, the disclosed methods can be combined with insertion/implantation of (or pre-existing) posterior stabilization devices/devices. Posterior stabilization can be in the form of: flexible (dynamic), semi-rigid or rigid implants such as pedicle screws, interspinous spacers or facet screws or any other fixation/fixation known in the art or subsequently developed. stabilization method.

第一和第二椎间元件可以同时被引入，即以“预组装的”构型。替代地，可以依次引入第一和第二椎间元件，在原位进行和/或实现第一和第二椎间元件的并排组装/定位。为此在第一与第二椎间元件之间定位第三元件(例如，聚合物片材或块体)，这样的中间第三元件可以在将植入体解剖学地定位在希望的脊柱位置中之前相对于该第一和/或第二椎间元件定位，或者可以例如，在将第一和/或第二椎间元件引入该解剖学位置之后按顺序地引入。The first and second intervertebral elements may be introduced simultaneously, ie in a "pre-assembled" configuration. Alternatively, the first and second intervertebral elements may be introduced sequentially, performing and/or enabling side-by-side assembly/positioning of the first and second intervertebral elements in situ. Position a third element (for example, a polymeric sheet or block) between the first and second intervertebral elements for this purpose, such an intermediate third element can anatomically position the implant at the desired spinal position Positioned relative to the first and/or second intervertebral element before, or may, for example, be introduced sequentially after the first and/or second intervertebral element is introduced into the anatomical position.

虽然已经参照本披露的示例性实施例描述了本披露，但是本披露不受此类示例性实施例的限制或不限于此。而是，可以对本文所披露的脊柱板进行多种不同修改、改进和/或改变而不背离本披露的精神或范围。例如，如本领域技术人员将从本披露立即了解的，通过使顶部和底部元件如所描述的匹配，可以设计和提供各种顶部和底部元件。例如，板的长度以及螺钉孔的数量可以变化。这些变化将使得能够对不同的解剖大小进行治疗。本披露明确地涵盖如本领域技术人员将了解的这些和其他修改、改进和/或改变。Although the present disclosure has been described with reference to exemplary embodiments of the present disclosure, the present disclosure is not limited to or by such exemplary embodiments. Rather, various modifications, improvements and/or changes may be made to the spine board disclosed herein without departing from the spirit or scope of the disclosure. For example, various top and bottom elements may be designed and provided by matching the top and bottom elements as described, as will be readily apparent to those skilled in the art from this disclosure. For example, the length of the plate and the number of screw holes can vary. These variations will enable treatment of different anatomical sizes. The present disclosure expressly covers these and other modifications, improvements and/or changes as would occur to those skilled in the art.

Claims (17)

Translated fromChinese

1.一种脊柱板，包括：1. A spine board comprising:a.第一和第二元件，这两个元件限定了多个间隔开的片状部，这些片状部被配置成且尺寸被确定成相对于彼此交错；以及a. first and second elements defining a plurality of spaced apart laminae configured and dimensioned to be staggered relative to each other; andb.用于将该第一和第二元件相对于彼此固定的紧固机构。b. Fastening means for securing the first and second elements relative to each other.2.根据权利要求1所述的脊柱板，其中，该第一和第二元件限定了弧形几何形状。2. The spinal board of claim 1, wherein the first and second members define an arcuate geometry.3.根据权利要求1所述的脊柱板，其中，该紧固机构包括多个孔口，这些孔口至少部分地延伸穿过该第一和第二元件中的至少一者。3. The spinal board of claim 1, wherein the fastening mechanism includes apertures extending at least partially through at least one of the first and second members.4.根据权利要求3所述的脊柱板，其中，该紧固机构进一步包括紧固构件，该紧固构件被适配成用于将该第一元件相对于该第二元件固定。4. The spinal board of claim 3, wherein the fastening mechanism further comprises a fastening member adapted to secure the first element relative to the second element.5.根据权利要求1所述的脊柱板，进一步包括一个或多个结构元件，这些结构元件被适配成利于该脊柱板相对于植入体的连接。5. The spinal board of claim 1, further comprising one or more structural elements adapted to facilitate attachment of the spinal board relative to the implant.6.根据权利要求1所述的脊柱板与相关地连接至其上的植入体的组合。6. A combination of a spinal board according to claim 1 and an implant associated thereto.7.根据权利要求6所述的组合，其中，在植入之前该脊柱板被连接至该植入体上。7. The combination of claim 6, wherein the spinal plate is attached to the implant prior to implantation.8.一种植入体组件，包括：8. An implant assembly comprising:a.植入体上部元件，该植入体上部元件包括直立凸缘和从该直立凸缘延伸的第一椎间元件，其中该植入体上部元件进一步限定了(i)由第一和第二弧形边界壁界定的开口、以及(ii)在该直立凸缘中形成的用于接纳锁定构件的开口；以及a. The implant superior element, the implant superior element comprises an upright flange and a first intervertebral element extending from the upright flange, wherein the implant superior element further defines (i) a first and a second intervertebral element the opening defined by the two arcuate boundary walls, and (ii) the opening formed in the upstanding flange for receiving the locking member; andb.植入体下部元件，该植入体下部元件包括凸缘部分以及从该凸缘部分延伸的第二椎间元件，其中该第二椎间元件进一步限定了直立接片，该直立接片限定了至少一个弧形面并且被配置成且尺寸被确定成用于被接纳在该植入体上部元件的、由第一和第二边界壁限定的该开口中。b. An inferior implant element comprising a flange portion and a second intervertebral element extending from the flange portion, wherein the second intervertebral element further defines an upstanding tab, the upstanding tab At least one arcuate surface is defined and configured and dimensioned for receipt in the opening of the implant superior element defined by the first and second boundary walls.9.根据权利要求8所述的植入体组件，其中，该直立接片限定了相对的弧形面。9. The implant assembly of claim 8, wherein the upstanding tabs define opposing arcuate surfaces.10.根据权利要求8所述的植入体组件，其中，当该植入体上部元件相对于该植入体下部元件被组装时，该直立接片交错在该第一与第二边界壁之间。10. The implant assembly of claim 8, wherein the upstanding tabs are staggered between the first and second boundary walls when the superior implant element is assembled relative to the inferior implant element between.11.根据权利要求8所述的植入体组件，其中，该植入体下部元件的直立接片和该植入体上部元件的由第一和第二弧形边界壁界定的开口容许在该植入体下部元件与该植入体上部元件之间的屈曲/伸展旋转移动自由度，直至该植入体上部元件和该植入体下部元件相对于彼此固定。11. The implant assembly according to claim 8, wherein the upright tab of the inferior implant element and the opening defined by the first and second arcuate boundary walls of the implant superior element allow Flexion/extension rotational movement between the inferior implant element and the superior implant element Freedom of movement until the superior implant element and the inferior implant element are fixed relative to each other.12.根据权利要求8所述的植入体组件，其中，该直立凸缘和该凸缘部分包括协作的弧形面。12. The implant assembly of claim 8, wherein the upstanding flange and the flange portion include cooperating arcuate surfaces.13.根据权利要求8所述的植入体组件，其中，该直立凸缘包括至少一个孔口，以利于相对于解剖学结构的安装该植入体上部元件。13. The implant assembly of claim 8, wherein the upstanding flange includes at least one aperture to facilitate mounting of the implant superior element relative to an anatomical structure.14.根据权利要求8所述的植入体组件，其中，该凸缘部分包括至少一个孔口，以利于相对于解剖学结构的安装该植入体下部元件。14. The implant assembly of claim 8, wherein the flange portion includes at least one aperture to facilitate mounting of the inferior implant element relative to an anatomical structure.15.根据权利要求8所述的植入体组件，其中，在该直立凸缘中形成的、用于接纳锁定构件的该开口是带螺纹的。15. The implant assembly of claim 8, wherein the opening formed in the upstanding flange for receiving a locking member is threaded.16.根据权利要求8所述的植入体组件，进一步包括锁定构件，该锁定构件被配置成且尺寸被确定成用于与在该直立凸缘中形成的、用于接纳锁定构件的该开口相协作。16. The implant assembly of claim 8, further comprising a locking member configured and dimensioned for mating with the opening formed in the upstanding flange for receiving a locking member cooperate.17.根据权利要求8所述的植入体组件，其中，该第一椎间元件和第二椎间元件包括准许骨长入的开口。17. The implant assembly of claim 8, wherein the first and second intervertebral elements include openings to permit bone ingrowth.